Amoxicillin
Capsule · Oral
Uses
1. INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the Genitourinary Tract : Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Escherichia coli, Proteus mirabilis , or Enterococcus faecalis . Infections of the Skin and Skin Structure: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α-and β-hemolytic isolates only), Staphylococcus spp., or E. coli . Infections of the Lower Respiratory Tract: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus spp. (α-and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae . Adults Patients only Helicobacter pylori Infection and Duodenal Ulcer Disease : Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole : Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori . Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole : Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected . (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AMOXICILLIN is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms.( 1 ) Adults and Pediatric Patients (1) Upper Respirtory Tract Infections of the Ear, Nose, and Throat Infections of the Genitourinary Tract Infections of the Skin and Skin Structure Infections of the Lower Respiratory Tract Adults Patients only (1) Helicobacter pylori Infection and Duodenal Ulcer Disease Usage : To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Dosage and administration
In Adults, 750-1750 mg/day in divided doses every 8 to 12 hours. In Pediatric Patients over 3 Months of Age, 20 to 45 mg/kg/day in divided doses every 8 to 12 hours. Refer to full prescribing information for specific dosing regimens. ( 2.2 , 2.3 ) The upper dose for neonates and infants age 3 months or younger is 30 mg/kg/day divided every 12 hours. ( 2.3 ) Dosing for H. pylori Infection (in Adults): Triple therapy: 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. ( 2.4 ) Reduce the dose in patients with severe renal impairment (GFR greater than 30 mL/min). ( 2.5 ) 2.1 Important Administration Instructions To minimize the potential for gastrointestinal intolerance, Amoxicillin should be taken at the start of a meal. 2.2 Dosage for Adults and for Pediatric Patients Aged 3 Months (12 weeks) and Older Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained. It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and Older Infection Severity a Recommended Dosage for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg R ecommended Dosage for Pediatric Patients Aged 3 Months and Older and Weight Less than 40 kg Ear/Nose/Throat Skin/Skin Structure Genitourinary Tract Mild/Moderate 500 mg every 12 hour or 250 mg every 8 hours 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours Lower Respiratory Tract Mild/Moderate or Severe 875 mg every 12 hours or 500 mg every 8 hours 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours a Dosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections. 2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months) It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever. Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function. Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained. 2.4 Dosing for H. pylori Infection in Adults Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days. Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days. Please refer to clarithromycin and lansoprazole full prescribing information. 2.5 Dosing in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of less than 30 mL/min should NOT receive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2. Table 2. Dosing in Patients with Severe Renal Impairment Patients with Renal Impairment Dosage Regimen GFR 10 to 30 mL/min 500 mg or 250 mg every 12 hours, depending on the severity of the infection GFR less than 10 mL/min 500 mg or 250 mg every 24 hours, depending on severity of the infection Hemodialysis 500 mg or 250 mg every 24 hours, depending on severity of the infection Administer an additional dose both during and at the end of dialysis 2.6 Directions for Mixing Oral Suspension Prepare a suspension at time of dispensing as follows: Tap bottle until all powder flows freely. Measure the total amount of water (see Table 3). Add approximately 1/3 of the water to powder. Replace cap and shake vigorously to wet powder. Add remaining water and again shake vigorously . Table 3. Amount of Water For Mixing Oral Suspension Strength Bottle Size Total Amount of Water Required for Reconstitution For Oral Suspension 200 mg/5 mL 50 mL 39 mL 75 mL 57 mL 100 mL 76 mL For Oral Suspension 400 mg/5 mL 50 mL 36 mL 75 mL 54 mL 100 mL 71 mL After reconstitution, the required amount of suspension should be placed directly on the child's tongue for swallowing. Alternate means of administration are to add the required amount of suspension to formula, milk, fruit juice, water, ginger ale, or cold drinks. These preparations should then be taken immediately. SHAKE ORAL SUSPENSION WELL BEFORE USING. Keep bottle tightly closed. Any unused portion of the reconstituted suspension must be discarded after 14 days. Refrigeration is preferable, but not required.
Dosage forms and strengths
Amoxicillin: Tablets : 500 mg, 875 mg. Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. For Oral Suspension: 200 mg/5 mL, 400 mg/5 mL. Each 5 mL of reconstituted bubble-gum flavored suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. Chewable Tablets: 125 mg – Each 125 mg cherry-banana-peppermint flavored tablet contains 125 mg of amoxicillin as the trihydrate. Each pale pink, oval tablet is imprinted with AMOXIL on one side and 125 on the other. 200 mg – Each 200 mg cherry-banana-peppermint flavored tablet contains 200 mg of amoxicillin as the trihydrate. Each pale pink, round convex tablet is imprinted with AMOXIL and 200 along the edge of 1 side. 250 mg – Each 250 mg cherry-banana-peppermint flavored tablet contains 250 mg of amoxicillin as the trihydrate. Each pale pink, oval tablet is imprinted with AMOXIL on one side and 250 on the other. 400 mg – Each 400 mg cherry-banana-peppermint flavored tablet contains 400 mg of amoxicillin as the trihydrate. Each pale pink, round convex tablet is imprinted with AMOXIL and 400 along the edge of 1 side. Tablets: 500 mg, 875 mg ( 3 ) For Oral Suspension: 200 mg/5 mL, 400 mg/5 mL ( 3 ) Chewable Tablets:125 mg, 200 mg, 250 mg, 400 mg ( 3 )
Contraindications
4 CONTRAINDICATIONS AMOXIL is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to AMOXIL or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins). History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to Amoxicillin or to other beta-lactams (e.g., penicillins or cephalosporins). ( 4 )
Warnings and precautions
Anaphylactic reactions: Serious and occasionally fatal anaphylactic reactions have been reported in patients on penicillin therapy, including amoxicillin. Discontinue Amoxicillin if a reaction occurs ( 5.1 ). Severe cutaneous adverse reactions (SCAR): Monitor closely. Discontinue if rash progresses. ( 5.2 ) Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use. If this occurs, discontinue Amoxicillin and institute appropriate therapy. ( 5.3 ) Clostridioides difficile -associated diarrhea (CDAD)(ranging from mild diarrhea to fatal colitis): Evaluate if diarrhea occurs. ( 5.4 ) 5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including amoxicillin. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins. Before initiating therapy with amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, amoxicillin should be discontinued, and appropriate therapy instituted. 5.2 Severe Cutaneous Adverse Reactions Amoxicillin may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop skin rash they should be monitored closely, and amoxicillin discontinued if lesions progress. 5.3 Drug-Induced Enterocolitis Syndrome (DIES) Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use [see Adverse Reactions ( 6.2 )] , with most cases occurring in pediatric patients < 18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue Amoxicillin and institute appropriate therapy. 5.4 Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. 5.5 Development of Drug-Resistant Bacteria Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 5.6 Skin Rash in Patients with Mononucleosis A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin should not be administered to patients with mononucleosis. 5.7 Phenylketonurics Aamoxicillin chewable tablets contain aspartame which contains phenylalanine. Each 200 mg chewable tablet contains 1.82 mg phenylalanine; each 400 mg chewable tablet contains 3.64 mg phenylalanine. The oral suspension formulations of Amoxicillin do not contain phenylalanine and can be used by phenylketonurics.
Side effects
The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin tablets or oral suspension were diarrhea, rash, vomiting, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact USAntibiotics, LLC at 1-844-454-5532 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin tablets or oral suspension were diarrhea, rash, vomiting, and nausea. Triple therapy : The most frequently reported adverse events for patients who received triple therapy (amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%). Dual therapy : The most frequently reported adverse events for patients who received double therapy amoxicillin/lansoprazole were diarrhea (8%) and headache (7%). For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts. 6.2 Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to amoxicillin. Infections and Infestations: Mucocutaneous candidiasis. Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions ( 5.4 )] . Immune : Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions ( 5.1 )]. Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis . Liver: A moderate rise in AST and/or ALT has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported. Renal: Crystalluria has been reported [see Overdosage ( 10 )] . Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported . These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Central Nervous System: Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, aseptic meningitis, and/or dizziness have been reported. Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Drug interactions
Co-administration with probenicid is not recommended. ( 7.1 ) Concomitant use of amoxicillin and oral anticoagulants may increase the prolongation of prothrombin time. ( 7.2 ) Co-administration with allopurinol increases the risk of rash. ( 7.3 ) Amoxicillin may reduce the efficacy of oral contraceptives. ( 7.4 ) 7.1 Probenecid Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin. 7.2 Oral Anticoagulants Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants. Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation. 7.3 Allopurinol The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of rashes is due to allopurinol or the hyperuricemia present in these patients. 7.4 Oral Contraceptives Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. 7.5 Other Antibacterials Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro ; however, the clinical significance of this interaction is not well documented. 7.6 Effects on Laboratory Tests High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ® , Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ® ) be used. Following administration of ampicillin or amoxicillin to pregnant women, a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone, and estradiol has been noted.
Use in specific populations
8.1 Pregnancy Teratogenic Effects : Pregnancy Category B. Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed. 8.2 Labor and Delivery Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. 8.3 Nursing Mothers Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman. 8.4 Pediatric Use The safety and effectiveness of AMOXIL for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients. The safety and effectiveness of AMOXIL for the treatment of H.Pylori infection have not been established in pediatric patients. Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of AMOXIL should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration ( 2. 3)]. 8.5 Geriatric Use An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. 8.6 Dosing in Renal Impairment Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Dosing in Renal Impairment ( 2.5 ) for specific recommendations in patients with renal impairment.
Overdosage
In case of overdosage, discontinue amoxicillin, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms. Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1 . Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria. Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.
Description
Amoxicillin is a semisynthetic antibacterial, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S ,5 R ,6 R )-6-[( R )-(-)-2-amino-2-( p -hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C 16 H 19 N 3 O 5 S·3H 2 O, and the molecular weight is 419.45. Tablets: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875, respectively. The 875-mg tablet is scored on the reverse side. Inactive ingredients in each 500 mg or 875 mg tablet: Colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide. For Oral Suspension: Each 5 mL of reconstituted suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. Each 5 mL of the 200-mg reconstituted suspension contains 0.15 mEq (3.39 mg) of sodium. Each 5 mL of the 400-mg reconstituted suspension contains 0.19 mEq (4.33 mg) of sodium. Inactive ingredients: flavorings, silica gel, sodium benzoate, sodium citrate, sucrose, and xanthan gum. Chewable Tablets: Each tablet contains 125 mg or 200 mg or 250 mg or 400 mg of amoxicillin as the trihydrate. Inactive ingredients in each 125 mg or 250 mg chewable tablet: Mannitol, glycine, magnesium stearate, silica gel, flavorings, citric acid, saccharin sodium, and confectioner’s sugar. Inactive ingredients in each 200 mg and 400 mg chewable tablet: Mannitol, crospovidone, flavorings, magnesium stearate, and aspartame [see Warnings and Precautions ( 5.7 ) ]. Amoxicillin Molecule
How supplied
16 HOW SUPPLIED/STORAGE AND HANDLING A moxicillin tablets, USP: Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate. Each film-coated, capsule-shaped, pink tablet is debossed with AMOXIL centered over 500 or 875 on one side, respectively. The 875 mg tablet is scored on the reverse side. 500 mg Tablet NDC 81964-224-01 Bottles of 100 NDC 81964-224-05 Bottles of 500 NDC 81964-224-14 Bottles of 20 875 mg Tablet NDC 81964-219-01 Bottles of 100 NDC 81964-219-14 Bottles of 20 A moxicillin for oral suspension, USP : Each 5 mL of reconstituted bubble-gum-flavored suspension contains 200 mg or 400 mg amoxicillin as the trihydrate. The powder for each strength is white to off-white in color and white to off-white when the product is reconstituted. 200 mg/5 mL NDC 81964-223-50 50-mL bottle NDC 81964-223-51 75-mL bottle NDC 81964-223-52 100-mL bottle 400 mg/5 mL NDC 81964-207-50 50-mL bottle NDC 81964-207-51 75-mL bottle NDC 81964-207-52 100-mL bottle A moxicillin chewable tablets: USP: 125 mg – Each 125 mg cherry-banana-peppermint flavored tablet contains 125 mg of amoxicillin as the trihydrate. Each pale pink, oval tablet is imprinted with AMOXIL on one side and 125 on the other. 200 mg – Each 200 mg cherry-banana-peppermint flavored tablet contains 200 mg of amoxicillin as the trihydrate. Each pale pink, round convex tablet is imprinted with AMOXIL and 200 along the edge of 1 side. 250 mg – Each 250 mg cherry-banana-peppermint flavored tablet contains 250 mg of amoxicillin as the trihydrate. Each pale pink, oval tablet is imprinted with AMOXIL on one side and 250 on the other. 400 mg – Each 400 mg cherry-banana-peppermint flavored tablet contains 400 mg of amoxicillin as the trihydrate. Each pale pink, round convex tablet is imprinted with AMOXIL and 400 along the edge of 1 side. 125 mg chewable tablets NDC 81964-226-60 Bottles of 60 NDC 81964-226-01 Bottles of 100 200 mg chewable tablets NDC 81964-228-14 Unit dose (4 x 5) 20 chewable tablets 250 mg chewable tablets NDC 81964-227-30 Bottles of 30 NDC 81964-227-01 Bottles of 100 400 mg chewable tablets NDC 81964-229-14 Unit dose (4 x 5) 20 chewable tablets NDC 81964-229-01 Bottles of 100 Store at or below 25° C (77° F) . Dispense in a tight container.
Label text from the FDA structured product label by USAntibiotics, LLC (revised Jul 7, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Amoxicillin in 271 products
Amoxicillin NDC products (271)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0304 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0709 | Amoxicillin 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-0455 | Amoxicillin 250 mg/1 Tablet, Chewable | A-S Medication Solutions | ANDA |
| 50090-0454 | Amoxicillin 250 mg/1 Tablet, Chewable | A-S Medication Solutions | ANDA |
| 50090-0411 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-0407 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-0406 | Amoxicillin 125 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-0405 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-0404 | Amoxicillin 125 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-0713 | Amoxicillin 875 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-0303 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0302 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0301 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1811 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1812 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1813 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1825 | Amoxicillin 500 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1826 | Amoxicillin 250 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-0714 | Amoxicillin 875 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-0858 | Amoxicillin 400 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-1086 | Amoxicillin 400 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-1347 | Amoxicillin 400 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-1511 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1512 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1513 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1514 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1595 | Amoxicillin 875 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1596 | Amoxicillin 875 mg/1 Tablet, Film Coated | A-S Medication Solutions | ANDA |
| 50090-1794 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1795 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1796 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1797 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-1810 | Amoxicillin 500 mg/1 Capsule | A-S Medication Solutions | ANDA |
| 50090-6319 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6323 | Amoxicillin 400 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6349 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6351 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6355 | Amoxicillin 400 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6469 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6680 | Amoxicillin 400 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6791 | Amoxicillin 125 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-6056 | Amoxicillin 125 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 50090-5880 | Amoxicillin 875 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-5863 | Amoxicillin 875 mg/1 Tablet, Coated | A-S Medication Solutions | ANDA |
| 50090-2251 | Amoxicillin 250 mg/5mL Powder, For Suspension | A-S Medication Solutions | ANDA |
| 80425-0269 | Amoxicillin 500 mg/1 Capsule | Advanced Rx Pharmacy of Tennessee, LLC | ANDA |
| 60687-776 | Amoxicillin 250 mg/1 Capsule | American Health Packaging | ANDA |
| 60687-787 | Amoxicillin 500 mg/1 Capsule | American Health Packaging | ANDA |
| 60687-798 | Amoxicillin 500 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 60687-809 | Amoxicillin 875 mg/1 Tablet, Film Coated | American Health Packaging | ANDA |
| 76420-838 | Amoxicillin 500 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 76420-871 | Amoxicillin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-833 | Amoxicillin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-832 | Amoxicillin 250 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-819 | Amoxicillin 400 mg/5mL Powder, For Suspension | Asclemed USA, Inc. | ANDA |
| 76420-573 | Amoxicillin 250 mg/5mL Powder, For Suspension | Asclemed USA, Inc. | ANDA |
| 76420-545 | Amoxicillin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-508 | Amoxicillin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-192 | Amoxicillin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-138 | Amoxicillin 875 mg/1 Tablet, Coated | Asclemed USA, Inc. | ANDA |
| 76420-112 | Amoxicillin 500 mg/1 Capsule | Asclemed USA, Inc. | ANDA |
| 76420-003 | Amoxicillin 875 mg/1 Tablet, Film Coated | Asclemed USA, Inc. | ANDA |
| 65862-707 | Amoxicillin 250 mg/5mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 65862-015 | Amoxicillin 875 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-014 | Amoxicillin 500 mg/1 Tablet, Film Coated | Aurobindo Pharma Limited | ANDA |
| 65862-016 | Amoxicillin 250 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 65862-017 | Amoxicillin 500 mg/1 Capsule | Aurobindo Pharma Limited | ANDA |
| 65862-070 | Amoxicillin 200 mg/5mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 65862-071 | Amoxicillin 400 mg/5mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 65862-706 | Amoxicillin 125 mg/5mL Powder, For Suspension | Aurobindo Pharma Limited | ANDA |
| 63629-7802 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7633 | Amoxicillin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7801 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7798 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-4777 | Amoxicillin 875 mg/1 Tablet, Film Coated | Bryant Ranch Prepack | ANDA |
| 63629-5512 | Amoxicillin 250 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5730 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5738 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-5739 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7584 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7585 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 63629-7587 | Amoxicillin 500 mg/1 Capsule | Bryant Ranch Prepack | ANDA |
| 68999-083 | Amoxicillin 500 mg/1 Capsule | Chartwell Governmental & Specialty RX, LLC | ANDA |
| 68999-824 | Amoxicillin 250 mg/1 Capsule | Chartwell Governmental & Specialty RX, LLC | ANDA |
| 68999-825 | Amoxicillin 500 mg/1 Capsule | Chartwell Governmental & Specialty RX, LLC | ANDA |
| 62135-087 | Amoxicillin 250 mg/1 Tablet, Chewable | Chartwell RX, LLC | ANDA |
| 62135-086 | Amoxicillin 125 mg/1 Tablet, Chewable | Chartwell RX, LLC | ANDA |
| 62135-085 | Amoxicillin 875 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-084 | Amoxicillin 500 mg/1 Tablet, Film Coated | Chartwell RX, LLC | ANDA |
| 62135-083 | Amoxicillin 500 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 62135-082 | Amoxicillin 250 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 62135-088 | Amoxicillin 200 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-089 | Amoxicillin 250 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-090 | Amoxicillin 400 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-109 | Amoxicillin 125 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-776 | Amoxicillin 125 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-777 | Amoxicillin 250 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-815 | Amoxicillin 400 mg/5mL Powder, For Suspension | Chartwell RX, LLC | ANDA |
| 62135-824 | Amoxicillin 250 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 62135-825 | Amoxicillin 500 mg/1 Capsule | Chartwell RX, LLC | ANDA |
| 67046-1175 | Amoxicillin 500 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-0316 | Amoxicillin 500 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-0127 | Amoxicillin 250 mg/1 Capsule | Coupler LLC | ANDA |
| 67046-0734 | Amoxicillin 875 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 67046-0015 | Amoxicillin 875 mg/1 Tablet, Film Coated | Coupler LLC | ANDA |
| 61919-401 | Amoxicillin 400 mg/5mL Powder, For Suspension | DIRECT RX | ANDA |
| 72189-463 | Amoxicillin 875 mg/1 Tablet, Film Coated | Direct_Rx | ANDA |
| 72189-285 | Amoxicillin 400 mg/5mL Powder, For Suspension | DirectRx | ANDA |
| 85534-0073 | Amoxicillin 400 mg/5mL Powder, For Suspension | HAWAII REPACK, INC. | ANDA |
| 85534-0040 | Amoxicillin 500 mg/1 Capsule | HAWAII REPACK, INC. | ANDA |
| 85534-0070 | Amoxicillin 125 mg/5mL Powder, For Suspension | HAWAII REPACK, INC. | ANDA |
| 85534-0071 | Amoxicillin 200 mg/5mL Powder, For Suspension | HAWAII REPACK, INC. | ANDA |
| 85534-0072 | Amoxicillin 250 mg/5mL Powder, For Suspension | HAWAII REPACK, INC. | ANDA |
| 0143-9889 | Amoxicillin 250 mg/5mL Powder, For Suspension | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9939 | Amoxicillin 500 mg/1 Capsule | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9888 | Amoxicillin 125 mg/5mL Powder, For Suspension | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9887 | Amoxicillin 400 mg/5mL Powder, For Suspension | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9886 | Amoxicillin 200 mg/5mL Powder, For Suspension | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9285 | Amoxicillin 875 mg/1 Tablet, Coated | Hikma Pharmaceuticals USA Inc. | ANDA |
| 42571-233 | Amoxicillin 250 mg/1 Capsule | Micro Labs Limited | ANDA |
| 42571-234 | Amoxicillin 500 mg/1 Capsule | Micro Labs Limited | ANDA |
| 16714-298 | Amoxicillin 250 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 16714-299 | Amoxicillin 500 mg/1 Capsule | NorthStar Rx LLC | ANDA |
| 82868-063 | Amoxicillin 250 mg/1 Tablet, Chewable | Northwind Health Company, LLC | ANDA |
| 82868-056 | Amoxicillin 500 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 82868-072 | Amoxicillin 250 mg/1 Capsule | Northwind Health Company, LLC | ANDA |
| 51655-156 | Amoxicillin 500 mg/1 Capsule | Northwind Pharmaceuticals, LLC | ANDA |
| 68071-3662 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceutials,Inc. | ANDA |
| 68071-3678 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals Inc. | ANDA |
| 66267-022 | Amoxicillin 250 mg/1 Tablet, Chewable | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3675 | Amoxicillin 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3716 | Amoxicillin 875 mg/1 Tablet, Coated | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3235 | Amoxicillin 250 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3119 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals, Inc. | ANDA |
| 68071-3517 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2911 | Amoxicillin 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2558 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2397 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2364 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1761 | Amoxicillin 125 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4944 | Amoxicillin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1760 | Amoxicillin 125 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3574 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3872 | Amoxicillin 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-3890 | Amoxicillin 500 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4455 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4468 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4548 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4574 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4581 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4698 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4724 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4741 | Amoxicillin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4796 | Amoxicillin 400 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4907 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4920 | Amoxicillin 500 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4953 | Amoxicillin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-1675 | Amoxicillin 400 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5288 | Amoxicillin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5127 | Amoxicillin 400 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 66267-871 | Amoxicillin 250 mg/1 Tablet, Chewable | NuCare Pharmaceuticals,Inc. | ANDA |
| 66267-993 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 66267-994 | Amoxicillin 250 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5096 | Amoxicillin 875 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5019 | Amoxicillin 250 mg/1 Capsule | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4982 | Amoxicillin 875 mg/1 Tablet, Film Coated | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4969 | Amoxicillin 125 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-5109 | Amoxicillin 400 mg/5mL Powder, For Suspension | NuCare Pharmaceuticals,Inc. | ANDA |
| 43063-885 | Amoxicillin 875 mg/1 Tablet, Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-915 | Amoxicillin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 55289-182 | Amoxicillin 250 mg/1 Tablet, Chewable | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-225 | Amoxicillin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-224 | Amoxicillin 875 mg/1 Tablet, Coated | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-820 | Amoxicillin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-574 | Amoxicillin 250 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 43063-341 | Amoxicillin 250 mg/1 Tablet, Chewable | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-254 | Amoxicillin 500 mg/1 Capsule | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8209 | Amoxicillin 500 mg/1 Capsule | Preferred Phamraceuticals Inc. | ANDA |
| 68788-8324 | Amoxicillin 200 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8325 | Amoxicillin 400 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8240 | Amoxicillin 250 mg/1 Capsule | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7414 | Amoxicillin 875 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-7323 | Amoxicillin 200 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4152 | Amoxicillin 875 mg/1 Tablet, Film Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4062 | Amoxicillin 875 mg/1 Tablet, Coated | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-4024 | Amoxicillin 125 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8730 | Amoxicillin 400 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8731 | Amoxicillin 400 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8759 | Amoxicillin 250 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8852 | Amoxicillin 200 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8611 | Amoxicillin 200 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-9948 | Amoxicillin 250 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-9949 | Amoxicillin 125 mg/5mL Powder, For Suspension | Preferred Pharmaceuticals, Inc. | ANDA |
| 82804-134 | Amoxicillin 250 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 82804-200 | Amoxicillin 875 mg/1 Tablet, Coated | Proficient Rx LP | ANDA |
| 71205-817 | Amoxicillin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-775 | Amoxicillin 200 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 71205-507 | Amoxicillin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 71205-436 | Amoxicillin 400 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 71205-422 | Amoxicillin 400 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 71205-266 | Amoxicillin 125 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 71205-177 | Amoxicillin 400 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 71205-035 | Amoxicillin 875 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-591 | Amoxicillin 250 mg/1 Capsule | Proficient Rx LP | ANDA |
| 63187-343 | Amoxicillin 250 mg/1 Tablet, Chewable | Proficient Rx LP | ANDA |
| 63187-335 | Amoxicillin 400 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 63187-325 | Amoxicillin 875 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-295 | Amoxicillin 125 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 63187-262 | Amoxicillin 400 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 63187-186 | Amoxicillin 250 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 63187-029 | Amoxicillin 250 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 63187-399 | Amoxicillin 500 mg/1 Capsule | Proficient Rx LP | ANDA |
| 63187-729 | Amoxicillin 875 mg/1 Tablet, Film Coated | Proficient Rx LP | ANDA |
| 63187-880 | Amoxicillin 250 mg/5mL Powder, For Suspension | Proficient Rx LP | ANDA |
| 42708-153 | Amoxicillin 500 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-076 | Amoxicillin 500 mg/1 Capsule | QPharma Inc | ANDA |
| 42708-010 | Amoxicillin 500 mg/1 Capsule | QPharma, Inc | ANDA |
| 42708-112 | Amoxicillin 875 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 42708-078 | Amoxicillin 875 mg/1 Tablet, Film Coated | QPharma, Inc. | ANDA |
| 67296-2295 | Amoxicillin 250 mg/1 Capsule | Redpharm Drug | ANDA |
| 67296-0002 | Amoxicillin 250 mg/1 Capsule | Redpharm Drug | ANDA |
| 67296-1894 | Amoxicillin 250 mg/1 Capsule | Redpharm Drug | ANDA |
| 67296-1914 | Amoxicillin 500 mg/1 Capsule | Redpharm Drug | ANDA |
| 67296-2292 | Amoxicillin 500 mg/1 Capsule | Redpharm Drug | ANDA |
| 67296-2328 | Amoxicillin 875 mg/1 Tablet, Coated | Redpharm Drug | ANDA |
| 70518-2191 | Amoxicillin 875 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3886 | Amoxicillin 500 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-0895 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-2188 | Amoxicillin 250 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-2190 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-2333 | Amoxicillin 875 mg/1 Tablet, Film Coated | REMEDYREPACK INC. | ANDA |
| 70518-3294 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3832 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4522 | Amoxicillin 400 mg/5mL Powder, For Suspension | REMEDYREPACK INC. | ANDA |
| 70518-4521 | Amoxicillin 400 mg/5mL Powder, For Suspension | REMEDYREPACK INC. | ANDA |
| 70518-4371 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-4279 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 70518-3914 | Amoxicillin 500 mg/1 Capsule | REMEDYREPACK INC. | ANDA |
| 57237-028 | Amoxicillin 500 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 57237-030 | Amoxicillin 250 mg/1 Capsule | Rising Pharma Holdings, Inc. | ANDA |
| 57237-031 | Amoxicillin 500 mg/1 Capsule | Rising Pharma Holdings, Inc. | ANDA |
| 57237-032 | Amoxicillin 200 mg/5mL Powder, For Suspension | Rising Pharma Holdings, Inc. | ANDA |
| 57237-033 | Amoxicillin 400 mg/5mL Powder, For Suspension | Rising Pharma Holdings, Inc. | ANDA |
| 57237-029 | Amoxicillin 875 mg/1 Tablet, Film Coated | Rising Pharma Holdings, Inc. | ANDA |
| 0781-6039 | Amoxicillin 125 mg/5mL Powder, For Suspension | Sandoz Inc | ANDA |
| 0781-2020 | Amoxicillin 250 mg/1 Capsule | Sandoz Inc | ANDA |
| 0781-2613 | Amoxicillin 500 mg/1 Capsule | Sandoz Inc | ANDA |
| 0781-5060 | Amoxicillin 500 mg/1 Tablet, Film Coated | Sandoz Inc | ANDA |
| 0781-5061 | Amoxicillin 875 mg/1 Tablet, Film Coated | Sandoz Inc | ANDA |
| 0781-6041 | Amoxicillin 250 mg/5mL Powder, For Suspension | Sandoz Inc | ANDA |
| 0781-6156 | Amoxicillin 200 mg/5mL Powder, For Suspension | Sandoz Inc | ANDA |
| 0781-6157 | Amoxicillin 400 mg/5mL Powder, For Suspension | Sandoz Inc | ANDA |
| 85766-021 | Amoxicillin 500 mg/1 Capsule | Sportpharm LLC | ANDA |
| 85766-185 | Amoxicillin 500 mg/1 Capsule | Sportpharm LLC | ANDA |
| 85766-267 | Amoxicillin 500 mg/1 Capsule | Sportpharm LLC | ANDA |
| 0093-2264 | Amoxicillin 875 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-4161 | Amoxicillin 400 mg/5mL Powder, For Suspension | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-4160 | Amoxicillin 200 mg/5mL Powder, For Suspension | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-4155 | Amoxicillin 250 mg/5mL Powder, For Suspension | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-3109 | Amoxicillin 500 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-3107 | Amoxicillin 250 mg/1 Capsule | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-2268 | Amoxicillin 250 mg/1 Tablet, Chewable | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-2267 | Amoxicillin 125 mg/1 Tablet, Chewable | Teva Pharmaceuticals USA, Inc. | ANDA |
| 0093-2263 | Amoxicillin 500 mg/1 Tablet, Film Coated | Teva Pharmaceuticals USA, Inc. | ANDA |
| 81964-350 | Amoxicillin 500 mg/1 Capsule | USAntibiotics, LLC | ANDA |
| 81964-225 | Amoxicillin 250 mg/1 Capsule | USAntibiotics, LLC | ANDA |
| 81964-205 | Amoxicillin 500 mg/1 Capsule | USAntibiotics, LLC | ANDA |
| 87063-058 | Amoxicillin 400 mg/5mL For Suspension | ASCLEMED USA INC. | NDA AUTHORIZED GENERIC |
| 68071-3925 | Amoxicillin 400 mg/5mL For Suspension | NuCare Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC |
| 70518-4529 | Amoxicillin 400 mg/5mL For Suspension | REMEDYREPACK INC. | NDA AUTHORIZED GENERIC |
| 81964-207 | Amoxicillin 400 mg/5mL For Suspension | USAntibiotics, LLC | NDA AUTHORIZED GENERIC |
Amoxicillin recalls
- D-0165-2024 Jan 3, 2024 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-0166-2024 Jan 3, 2024 · Class II · Terminated
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-1025-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse - D-0147-2017 Nov 30, 2016 · Class III · Terminated
Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed. - D-1470-2016 Aug 31, 2016 · Class II · Terminated
Superpotent drug: Out of specification test result for assay during stability testing. - D-803-2013 Jul 24, 2013 · Class III · Terminated
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050. - D-598-2013 Jun 19, 2013 · Class III · Terminated
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles. - D-268-2013 May 1, 2013 · Class II · Terminated
Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.
Frequently asked questions
What is Amoxicillin used for?
1. INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and β-hemolytic isolates only), Streptococcus pneumoniae , Staphylococcus spp., or Haemophilus influenzae . Infections of the…
What are the side effects of Amoxicillin?
The following are discussed in more detail in other sections of the labeling: Anaphylactic reactions [see Warnings and Precautions ( 5.1 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.2 )] Drug-Induced Enterocolitis Syndrome (DIES) [see Warnings and Precautions ( 5.3 )] Clostridioides difficile -Associated Diarrhea (CDAD) [see Warnings and Precautions ( 5.4 )] The most… See the full label for the complete list.
Who makes Amoxicillin?
Amoxicillin is listed by 38 labelers in the FDA NDC directory, including A-S Medication Solutions, Advanced Rx Pharmacy of Tennessee, LLC, American Health Packaging, Asclemed USA, Inc..
Has Amoxicillin been recalled?
The FDA enforcement database lists 8 recalls for Amoxicillin, most recently D-0165-2024 (class ii): CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.