Hydrocortisone
Cream · Topical, Oral, Rectal
Uses
Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative thyroiditis Hypercalcemia associated with cancer 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Serum sickness Bronchial asthma Contact dermatitis Atopic dermatitis Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic conjunctivitis Keratitis Allergic corneal marginal ulcers Herpes zoster ophthalmicus Iritis and iridocyclitis Chorioretinitis Anterior segment inflammation Diffuse posterior uveitis and choroiditis Optic neuritis Sympathetic ophthalmia 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler's syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus. 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement
Dosage and administration
The initial dosage of hydrocortisone tablets may vary from 20 mg to 240 mg of hydrocortisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, hydrocortisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient's individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of hydrocortisone for a period of time consistent with the patient's condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually, rather than abruptly.
Contraindications
Systemic fungal infections and known hypersensitivity to components
Warnings
In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including CORTEF, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can:
• Reduce resistance to new infections
• Exacerbate existing infections
• Increase the risk of disseminated infections
• Increase the risk of reactivation or exacerbation of latent infections
• Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal. The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider CORTEF withdrawal or dosage reduction as needed. Tuberculosis If CORTEF is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur. Closely monitor such patients for reactivation. During prolonged CORTEF therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including CORTEF. In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles:
• If a CORTEF-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered.
• If a CORTEF-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated. Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including CORTEF. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with CORTEF. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids, including CORTEF, may exacerbate systemic fungal infections; therefore, avoid CORTEF use in the presence of such infections unless CORTEF is needed to control drug reactions. For patients on chronic CORTEF therapy who develop systemic fungal infections, CORTEF withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including CORTEF, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating CORTEF in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including CORTEF, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteroids, including CORTEF, in patients with cerebral malaria. Ophthalmic Effects Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. Hypertension, Volume Overload, and Hypokalemia Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion. Vaccinations Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids. Usage in Pregnancy Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of child bearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism. Corticosteroids have been shown to impair fertility in male rats.
Precautions
General Precautions Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual. Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Pheochromocytoma crisis, which can be fatal, has been reported after administration of systemic corticosteroids. In patients with suspected pheochromocytoma, consider the risk of pheochromocytoma crisis prior to administering corticosteroids. In post marketing experience tumor lysis syndrome (TLS) has been reported in patients with malignancies, including hematological malignancies and solid tumors, following the use of systemic corticosteroids alone or in combination with other chemotherapeutic agents. Patients at high risk of TLS, such as patients with tumors that have a high proliferative rate, high tumor burden and high sensitivity to cytotoxic agents, should be monitored closely and appropriate precautions should be taken. Drug Interactions The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect. Information for the Patient Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
Side effects
Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment. These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Neurological Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Convulsions Vertigo Headache Epidural lipomatosis Endocrine Development of Cushingoid state Suppression of growth in children Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Menstrual irregularities Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Central serous chorioretinopathy Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism Blood and lymphatic system disorders Leukocytosis
Drug interactions
Drug Interactions The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance. Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.
Description
Hydrocortisone tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. Hydrocortisone tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose. Chemical Structure
Mechanism of action
Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.
How supplied
Hydrocortisone tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, imprinted CORTEF 5) Bottles of 50 NDC 59762-0073-1 10 mg (white, round, scored, imprinted CORTEF 10) Bottles of 100 NDC 59762-0074-1 20 mg (white, round, scored, imprinted CORTEF 20) Bottles of 100 NDC 59762-0075-1 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Storage
Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].
Patient information
Information for the Patient Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.
Label text from the FDA structured product label by Mylan Pharmaceuticals Inc. (revised May 25, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Hydrocortisone in 174 products
- Hydrocortisone Acetate in 9 products
Hydrocortisone NDC products (183)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 50090-0244 | Hydrocortisone 25 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-0350 | Hydrocortisone 25 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-0527 | Hydrocortisone 25 mg/g Ointment | A-S Medication Solutions | ANDA |
| 50090-2452 | Hydrocortisone 25 mg/g Cream | A-S Medication Solutions | ANDA |
| 50090-5999 | Hydrocortisone 25 mg/g Cream | A-S Medication Solutions | ANDA |
| 0472-0321 | Hydrocortisone 10 mg/g Cream | Actavis Pharma, Inc. | ANDA |
| 71297-010 | Hydrocortisone 20 mg/mL Lotion | Allegis Holdings LLC | ANDA |
| 60687-582 | Hydrocortisone 10 mg/1 Tablet | American Health Packaging | ANDA |
| 60687-844 | Hydrocortisone 5 mg/1 Tablet | American Health Packaging | ANDA |
| 0115-1697 | Hydrocortisone 10 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 0115-1696 | Hydrocortisone 5 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 0115-1700 | Hydrocortisone 20 mg/1 Tablet | Amneal Pharmaceuticals of New York LLC | ANDA |
| 62559-430 | Hydrocortisone 10 mg/g Cream | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-052 | Hydrocortisone 5 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-053 | Hydrocortisone 10 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 70954-054 | Hydrocortisone 20 mg/1 Tablet | ANI Pharmaceuticals, Inc. | ANDA |
| 62559-431 | Hydrocortisone 25 mg/g Cream | ANI Pharmaceuticals, Inc. | ANDA |
| 76420-110 | Hydrocortisone 5 mg/1 Tablet | Asclemed USA, Inc. | ANDA |
| 59651-413 | Hydrocortisone 5 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-415 | Hydrocortisone 20 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 59651-414 | Hydrocortisone 10 mg/1 Tablet | Aurobindo Pharma Limited | ANDA |
| 50268-405 | Hydrocortisone 5 mg/1 Tablet | AvPAK | ANDA |
| 50268-406 | Hydrocortisone 10 mg/1 Tablet | AvPAK | ANDA |
| 50268-407 | Hydrocortisone 20 mg/1 Tablet | AvPAK | ANDA |
| 72162-1382 | Hydrocortisone 25 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-2529 | Hydrocortisone 25 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 71335-2954 | Hydrocortisone 25 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 71335-2918 | Hydrocortisone 25 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 71335-2770 | Hydrocortisone 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-2044 | Hydrocortisone 20 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 71335-1989 | Hydrocortisone 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 63629-9416 | Hydrocortisone 25 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 63629-9057 | Hydrocortisone 25 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-8817 | Hydrocortisone 25 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-8668 | Hydrocortisone 25 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 63629-8667 | Hydrocortisone 25 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-8666 | Hydrocortisone 25 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-1951 | Hydrocortisone 10 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-1952 | Hydrocortisone 25 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 63629-2527 | Hydrocortisone 25 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 63629-2528 | Hydrocortisone 25 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 72162-1383 | Hydrocortisone 25 mg/g Ointment | Bryant Ranch Prepack | ANDA |
| 72162-2018 | Hydrocortisone 20 mg/1 Tablet | Bryant Ranch Prepack | ANDA |
| 72162-1764 | Hydrocortisone 25 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 72162-1441 | Hydrocortisone 25 mg/mL Lotion | Bryant Ranch Prepack | ANDA |
| 72162-1763 | Hydrocortisone 10 mg/g Cream | Bryant Ranch Prepack | ANDA |
| 62135-186 | Hydrocortisone 20 mg/1 Tablet | Chartwell RX, LLC | ANDA |
| 62135-552 | Hydrocortisone 10 mg/1 Tablet | Chartwell RX, LLC. | ANDA |
| 62135-551 | Hydrocortisone 5 mg/1 Tablet | Chartwell RX, LLC. | ANDA |
| 0316-0186 | Hydrocortisone 10 mg/g Cream | Crown Laboratories | ANDA |
| 0316-0193 | Hydrocortisone 25 mg/g Cream | Crown Laboratories | ANDA |
| 61919-364 | Hydrocortisone 25 mg/g Cream | DIRECT RX | ANDA |
| 72189-209 | Hydrocortisone 10 mg/g Cream | DIRECT RX | ANDA |
| 0168-0020 | Hydrocortisone 10 mg/g Ointment | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0146 | Hydrocortisone 25 mg/g Ointment | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0080 | Hydrocortisone 25 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 0168-0015 | Hydrocortisone 10 mg/g Cream | E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC | ANDA |
| 21922-065 | Hydrocortisone 25 mg/g Cream | Encube Ethicals, Inc. | ANDA |
| 71930-078 | Hydrocortisone 5 mg/1 Tablet | Eywa Pharma Inc | ANDA |
| 71930-079 | Hydrocortisone 10 mg/1 Tablet | Eywa Pharma Inc | ANDA |
| 71930-080 | Hydrocortisone 20 mg/1 Tablet | Eywa Pharma Inc | ANDA |
| 23155-926 | Hydrocortisone 100 mg/60mL Suspension | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc | ANDA |
| 0904-7188 | Hydrocortisone 10 mg/1 Tablet | Major Pharmaceuticals | ANDA |
| 66267-967 | Hydrocortisone 25 mg/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-2233 | Hydrocortisone 25 mg/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 68071-4511 | Hydrocortisone 25 mg/g Cream | NuCare Pharmaceuticals,Inc. | ANDA |
| 45802-004 | Hydrocortisone 25 mg/g Cream | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-014 | Hydrocortisone 25 mg/g Ointment | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 45802-937 | Hydrocortisone 25 mg/mL Lotion | Padagis Israel Pharmaceuticals Ltd | ANDA |
| 72789-228 | Hydrocortisone 10 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-229 | Hydrocortisone 20 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 72789-227 | Hydrocortisone 5 mg/1 Tablet | PD-Rx Pharmaceuticals, Inc. | ANDA |
| 68788-8583 | Hydrocortisone 25 mg/g Cream | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8455 | Hydrocortisone 5 mg/1 Tablet | Preferred Pharmaceuticals Inc. | ANDA |
| 68788-8302 | Hydrocortisone 25 mg/g Cream | Preferred Pharmaceuticals, Inc. | ANDA |
| 68788-9922 | Hydrocortisone 25 mg/g Cream | Preferred Pharmaceuticals, Inc. | ANDA |
| 82804-135 | Hydrocortisone 25 mg/g Cream | Proficient Rx LP | ANDA |
| 63187-480 | Hydrocortisone 25 mg/g Cream | Proficient Rx LP | ANDA |
| 82804-084 | Hydrocortisone 25 mg/g Ointment | Proficient Rx LP | ANDA |
| 70518-3078 | Hydrocortisone 25 mg/g Cream | REMEDYREPACK INC. | ANDA |
| 43547-893 | Hydrocortisone 10 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 43547-892 | Hydrocortisone 5 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 43547-894 | Hydrocortisone 20 mg/1 Tablet | Solco Healthcare LLC | ANDA |
| 85766-085 | Hydrocortisone 25 mg/g Cream | Sportpharm LLC | ANDA |
| 85766-081 | Hydrocortisone 25 mg/g Cream | Sportpharm LLC | ANDA |
| 42543-970 | Hydrocortisone 5 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 42543-971 | Hydrocortisone 10 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 42543-972 | Hydrocortisone 20 mg/1 Tablet | Strides Pharma Inc. | ANDA |
| 64380-971 | Hydrocortisone 10 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-970 | Hydrocortisone 5 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 64380-972 | Hydrocortisone 20 mg/1 Tablet | Strides Pharma Science Limited | ANDA |
| 51672-3003 | Hydrocortisone 25 mg/g Cream | Sun Pharmaceutical Industries, Inc. | ANDA |
| 73352-455 | Hydrocortisone 25 mg/mL Solution | Trifluent Pharma LLC | ANDA |
| 62559-138 | Hydrocortisone 100 mg/60mL Enema | ANI Pharmaceuticals, Inc. | NDA AUTHORIZED GENERIC |
| 76420-028 | Hydrocortisone 5 mg/1 Tablet | Asclemed USA, Inc. | NDA AUTHORIZED GENERIC |
| 59762-0075 | Hydrocortisone 20 mg/1 Tablet | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 59762-0074 | Hydrocortisone 10 mg/1 Tablet | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 59762-0073 | Hydrocortisone 5 mg/1 Tablet | Mylan Pharmaceuticals Inc. | NDA AUTHORIZED GENERIC |
| 50090-6526 | Hydrocortisone 1 g/100g Ointment | A-S Medication Solutions | OTC MONOGRAPH DRUG |
| 73141-622 | Hydrocortisone 10 mg/g Cream | A2A Integrated Pharmaceuticals, LLC | OTC MONOGRAPH DRUG |
| 0924-1133 | Hydrocortisone 10 mg/g Cream | Acme United Corporation | OTC MONOGRAPH DRUG |
| 71399-0180 | Hydrocortisone 1 mg/100g Cream | AKRON PHARMA INC | OTC MONOGRAPH DRUG |
| 71399-0120 | Hydrocortisone 10 mg/mL Lotion | AKRON PHARMA INC | OTC MONOGRAPH DRUG |
| 87236-004 | Hydrocortisone 1 g/100g Cream | Aldermed Inc. | OTC MONOGRAPH DRUG |
| 87236-003 | Hydrocortisone 1 g/100g Cream | Aldermed Inc. | OTC MONOGRAPH DRUG |
| 84387-005 | Hydrocortisone 10 mg/g Cream | ALLIED TRADE LINK LLC | OTC MONOGRAPH DRUG |
| 72288-713 | Hydrocortisone 1 g/100g Cream | Amazon.com Services LLC | OTC MONOGRAPH DRUG |
| 72288-469 | Hydrocortisone 1 g/100g Lotion | Amazon.com Services LLC | OTC MONOGRAPH DRUG |
| 46122-822 | Hydrocortisone 1 g/100g Cream | AMERISOURCE BERGEN | OTC MONOGRAPH DRUG |
| 68001-526 | Hydrocortisone Acetate 1 g/100g Ointment | BluePoint Laboratories | OTC MONOGRAPH DRUG |
| 68001-476 | Hydrocortisone 1 g/100g Cream | BluePoint Laboratories | OTC MONOGRAPH DRUG |
| 72162-2284 | Hydrocortisone 1 g/100g Ointment | Bryant Ranch Prepack | OTC MONOGRAPH DRUG |
| 72162-2283 | Hydrocortisone 1 g/100g Cream | Bryant Ranch Prepack | OTC MONOGRAPH DRUG |
| 70000-0489 | Hydrocortisone Acetate 1 g/100g Ointment | Cardinal Health | OTC MONOGRAPH DRUG |
| 70000-0485 | Hydrocortisone 1 g/100g Cream | Cardinal Health | OTC MONOGRAPH DRUG |
| 51316-227 | Hydrocortisone 10 mg/g Cream | CVS PHARMACY, INC | OTC MONOGRAPH DRUG |
| 51316-230 | Hydrocortisone 10 mg/g Cream | CVS PHARMACY, INC | OTC MONOGRAPH DRUG |
| 67777-004 | Hydrocortisone 1 g/100g Cream | Dynarex Corporation | OTC MONOGRAPH DRUG |
| 21922-096 | Hydrocortisone 1 g/100g Cream | Encube Ethicals, Inc. | OTC MONOGRAPH DRUG |
| 21922-098 | Hydrocortisone 1 g/100g Ointment | Encube Ethicals, Inc. | OTC MONOGRAPH DRUG |
| 81522-914 | Hydrocortisone 10 mg/mL Spray | FSA Store Inc. | OTC MONOGRAPH DRUG |
| 37808-471 | Hydrocortisone 1 g/100g Ointment | H E B | OTC MONOGRAPH DRUG |
| 37808-369 | Hydrocortisone 1 g/100g Cream | H E B | OTC MONOGRAPH DRUG |
| 37808-319 | Hydrocortisone 1 g/100g Cream | H E B | OTC MONOGRAPH DRUG |
| 37808-973 | Hydrocortisone 1 g/100g Cream | H E B | OTC MONOGRAPH DRUG |
| 50332-0042 | Hydrocortisone Acetate 10 mg/g Cream | HART Health | OTC MONOGRAPH DRUG |
| 50332-0092 | Hydrocortisone Acetate 10 mg/g Cream | HART Health | OTC MONOGRAPH DRUG |
| 0404-0166 | Hydrocortisone 1 g/100g Cream | Henry Schein | OTC MONOGRAPH DRUG |
| 51662-1284 | Hydrocortisone Acetate 1 g/100g Ointment | HF Acquisition Co LLC, DBA HealthFirst | OTC MONOGRAPH DRUG |
| 82942-1003 | Hydrocortisone 10 mg/g Cream | J&A Digital Inc. | OTC MONOGRAPH DRUG |
| 73598-1014 | Hydrocortisone Acetate .9 g/.9g Cream | JHK Inc dba American Safety & First Aid | OTC MONOGRAPH DRUG |
| 30142-411 | Hydrocortisone 1 g/100g Cream | Kroger Company | OTC MONOGRAPH DRUG |
| 30142-973 | Hydrocortisone 1 g/100g Cream | Kroger Company | OTC MONOGRAPH DRUG |
| 85402-001 | Hydrocortisone 1 g/100g Cream | Medrock Pharmacy LLC | OTC MONOGRAPH DRUG |
| 79481-9967 | Hydrocortisone 10 mg/mL Spray | Meijer Distribution Inc. | OTC MONOGRAPH DRUG |
| 0394-0859 | Hydrocortisone 1.14 g/114g Lotion | Mericon Industries | OTC MONOGRAPH DRUG |
| 43473-049 | Hydrocortisone 10 mg/g Cream | Nantong Health & Beyond Hygienic Products Inc. | OTC MONOGRAPH DRUG |
| 13709-316 | Hydrocortisone .0102 g/g Ointment | NeilMed Pharmaceuticals Inc | OTC MONOGRAPH DRUG |
| 68071-5305 | Hydrocortisone 1 g/100g Cream | NuCare Pharmaceuticals, Inc. | OTC MONOGRAPH DRUG |
| 68071-5205 | Hydrocortisone 1 g/100g Cream | NuCare Pharmaceuticals,Inc. | OTC MONOGRAPH DRUG |
| 80489-001 | Hydrocortisone 10 mg/g Cream | OL PHARMA TECH,LLC | OTC MONOGRAPH DRUG |
| 45802-438 | Hydrocortisone 1 g/100g Cream | Padagis Israel Pharmaceuticals Ltd | OTC MONOGRAPH DRUG |
| 45802-276 | Hydrocortisone 1 g/100g Ointment | Padagis Israel Pharmaceuticals Ltd | OTC MONOGRAPH DRUG |
| 87228-2010 | Hydrocortisone 1 mg/100g Cream | PHARMACY CHOICE INC | OTC MONOGRAPH DRUG |
| 68016-529 | Hydrocortisone 1 g/100g Cream | Pharmacy Value Alliance LLC | OTC MONOGRAPH DRUG |
| 68016-149 | Hydrocortisone 1 g/100g Cream | Pharmacy Value Alliance LLC | OTC MONOGRAPH DRUG |
| 68788-8078 | Hydrocortisone 1 g/100g Cream | Preferred Pharmaceuticals Inc. | OTC MONOGRAPH DRUG |
| 56104-250 | Hydrocortisone 1.13 g/113g Aerosol, Spray | Premier Brands of America, Inc. | OTC MONOGRAPH DRUG |
| 63187-575 | Hydrocortisone .5 g/100g Cream | Proficient Rx LP | OTC MONOGRAPH DRUG |
| 63187-543 | Hydrocortisone 1 g/100g Ointment | Proficient Rx LP | OTC MONOGRAPH DRUG |
| 63187-504 | Hydrocortisone 1 g/100g Cream | Proficient Rx LP | OTC MONOGRAPH DRUG |
| 71205-571 | Hydrocortisone 1 g/100g Cream | Proficient Rx LP | OTC MONOGRAPH DRUG |
| 11822-2069 | Hydrocortisone Acetate 1 g/100g Cream | Rite Aid Corporation | OTC MONOGRAPH DRUG |
| 11822-2090 | Hydrocortisone 1 g/100g Cream | RITE AID CORPORATION | OTC MONOGRAPH DRUG |
| 61010-5800 | Hydrocortisone 10 mg/g Cream | Safetec of America, Inc. | OTC MONOGRAPH DRUG |
| 21130-449 | Hydrocortisone 1 g/100g Cream | Safeway | OTC MONOGRAPH DRUG |
| 85766-151 | Hydrocortisone 1 g/100g Cream | Sportpharm LLC | OTC MONOGRAPH DRUG |
| 85766-166 | Hydrocortisone 10 mg/g Cream | Sportpharm LLC | OTC MONOGRAPH DRUG |
| 70677-1214 | Hydrocortisone 1 g/100g Ointment | STRATEGIC SOURCING SERVICES LLC | OTC MONOGRAPH DRUG |
| 70677-1216 | Hydrocortisone 1 g/100g Cream | STRATEGIC SOURCING SERVICES LLC | OTC MONOGRAPH DRUG |
| 51672-5330 | Hydrocortisone 1 g/100g Cream | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 51672-2010 | Hydrocortisone .5 g/100g Cream | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 51672-2013 | Hydrocortisone 1 g/100g Cream | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 51672-5335 | Hydrocortisone .5 g/100g Cream | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 51672-2018 | Hydrocortisone 1 g/100g Ointment | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 51672-2063 | Hydrocortisone 1 g/100g Cream | Sun Pharmaceutical Industries, Inc. | OTC MONOGRAPH DRUG |
| 11673-392 | Hydrocortisone 1 g/100g Cream | TARGET Corporation | OTC MONOGRAPH DRUG |
| 11673-399 | Hydrocortisone 1 g/100g Cream | TARGET Corporation | OTC MONOGRAPH DRUG |
| 11673-398 | Hydrocortisone 1 g/100g Cream | TARGET Corporation | OTC MONOGRAPH DRUG |
| 69396-003 | Hydrocortisone 1 g/100g Ointment | TRIFECTA PHARMACEUTICALS USA LLC | OTC MONOGRAPH DRUG |
| 69396-149 | Hydrocortisone 1 g/100g Ointment | TRIFECTA PHARMACEUTICALS USA LLC | OTC MONOGRAPH DRUG |
| 47682-933 | Hydrocortisone 10 mg/g Cream | Unifirst First Aid Corporation | OTC MONOGRAPH DRUG |
| 47682-397 | Hydrocortisone 10 mg/g Cream | Unifirst First Aid Corporation | OTC MONOGRAPH DRUG |
| 47682-211 | Hydrocortisone 10 mg/g Cream | Unifirst First Aid Corporation | OTC MONOGRAPH DRUG |
| 84722-3031 | Hydrocortisone 1 g/100g Cream | VIVE HEALTH LLC | OTC MONOGRAPH DRUG |
| 0363-0972 | Hydrocortisone Acetate 1 g/100g Cream | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-1973 | Hydrocortisone 1 g/100g Cream | Walgreen Company | OTC MONOGRAPH DRUG |
| 0363-0363 | Hydrocortisone 1 g/100g Gel | Walgreens | OTC MONOGRAPH DRUG |
| 0363-1333 | Hydrocortisone 1 g/100g Ointment | Walgreens Co. | OTC MONOGRAPH DRUG |
| 0363-9981 | Hydrocortisone 10 mg/g Cream | Walgreens Company | OTC MONOGRAPH DRUG |
| 59898-800 | Hydrocortisone Acetate 1 g/100g Ointment | Water-Jel Technologies | OTC MONOGRAPH DRUG |
| 11383-268 | Hydrocortisone 1 g/100g Ointment | Weeks & Leo Co., Inc. | OTC MONOGRAPH DRUG |
| 71741-455 | Hydrocortisone 20 mg/g Gel | Redmont Pharmaceuticals, LLC | UNAPPROVED DRUG OTHER |
Hydrocortisone recalls
- D-1045-2022 Jun 15, 2022 · Class II · Terminated
cGMP deviations: Temperature abuse - D-0817-2018 May 23, 2018 · Class II · Terminated
Failed Stability Specifications
Frequently asked questions
What is Hydrocortisone used for?
Hydrocortisone tablets are indicated in the following conditions. 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Non suppurative…
What are the side effects of Hydrocortisone?
Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture… See the full label for the complete list.
Who makes Hydrocortisone?
Hydrocortisone is listed by 78 labelers in the FDA NDC directory, including A-S Medication Solutions, Actavis Pharma, Inc., Allegis Holdings LLC, American Health Packaging.
Has Hydrocortisone been recalled?
The FDA enforcement database lists 2 recalls for Hydrocortisone, most recently D-1045-2022 (class ii): cGMP deviations: Temperature abuse