Azacitidine

Injection, Powder, Lyophilized, For Solution · Subcutaneous, Intravenous

Prescription (Rx) Nucleoside Metabolic Inhibitor In shortage 4 recalls

Current shortage

Azacitidine, Injection, 100 mg/ Vial (NDC 0143-9606-01) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots are scheduled for manufacturing to meet demand. Product will be made available as it is released.

Azacitidine, Injection, 100 mg (NDC 43598-305-62) – Available (Dr. Reddy's Laboratories, Inc., updated Aug 5, 2026)
Available to existing customers

Azacitidine, Injection, 100 mg (NDC 68001-313-56) – Unavailable (Teva Pharmaceuticals USA, Inc., updated Sep 15, 2026)
Estimated recovery: TBD

Azacitidine, Injection, 100 mg/4 mL (NDC 55150-393-01) – Unavailable (Eugia US LLC, updated Sep 17, 2026)
On backorder. Recovery: TBD. Check wholesalers for inventory

Azacitidine, Injection, 100 mg/30 mL (NDC 63323-771-39) – Unavailable (Fresenius Kabi USA, LLC, updated Sep 15, 2026)
Discontinuation of the manufacture of the drug

Azacitidine, Injection, 100 mg/30 mL (NDC 71288-115-30) – Available (Meitheal Pharmaceuticals, Inc., updated Aug 27, 2026)

Azacitidine, Injection, 100 mg (NDC 16729-306-10) – Available (Accord Healthcare Inc., updated Sep 15, 2026)

Azacitidine, Injection, 100 mg (NDC 72485-201-01) – Limited Availability (Armas Pharmaceuticals Inc, updated Jun 8, 2026)
Estimated recovery: TBD

Uses

Azacitidine for Injection is a nucleoside metabolic inhibitor indicated for the treatment of adult patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL) ( 1 ). 1.1 Myelodysplastic Syndromes (MDS) Azacitidine for Injection is indicated for treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information.

Dosage and administration

Do not substitute Azacitidine for Injection for oral azacitidine. The indications and dosing regimen for Azacitidine for Injection differ from that of oral azacitidine ( 2.1 , 5.1 ). The recommended starting dosage for the first treatment cycle, for all patients regardless of baseline hematology values, is Azacitidine for Injection 75 mg/m2 daily for 7 days to be administered by subcutaneous injection or intravenous infusion. See full prescribing information for schedule for subsequent cycles. Premedicate for nausea and vomiting ( 2.2 ). Continue treatment as long as the patient continues to benefit ( 2.3 ). Monitor all patients for hematologic response and for renal toxicity; delay or reduce dosage as appropriate ( 2.4 , 2.5 , 2.6 ). 2.1 Important Administration Information Do not substitute Azacitidine for Injection for oral azacitidine. The indications and dosing regimen for Azacitidine for Injection differ from that of oral azacitidine [ see Warnings and Precautions (5.1) ] . 2.2 First Treatment Cycle for Adults The recommended starting dose for the first treatment cycle, for all patients regardless of baseline hematology laboratory values, is 75 mg/m 2 subcutaneously or intravenously, daily for 7 days. Premedicate patients for nausea and vomiting. Obtain complete blood counts, liver chemistries and serum creatinine prior to the first dose. 2.3 Subsequent Treatment Cycles for Adults Repeat cycles every 4 weeks. The dose may be increased to 100 mg/m 2 if no beneficial effect is seen after 2 treatment cycles and if no toxicity other than nausea and vomiting has occurred. It is recommended that patients be treated for a minimum of 4 to 6 cycles. However, complete or partial response may require additional treatment cycles. Treatment may be continued as long as the patient continues to benefit. Monitor patients for hematologic response and renal toxicities [ see Warnings and Precautions (5.4) ] and delay or reduce dosage if necessary as described below. Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information. 2.4 Dosage Adjustment Based on Hematology Laboratory Values For adult patients with baseline (start of treatment) WBC greater than or equal to 3 x10 9 /L, ANC greater than or equal to 1.5 x10 9 /L, and platelets greater than or equal to 75 x10 9 /L, adjust the dose as follows, based on nadir counts for any given cycle: Nadir Counts % Dose in the Next Course ANC (x10 9 /L) Less than 0.5 0.5 to 1.5 Greater than 1.5 Platelets (x10 9 /L) Less than 25 25 to 50 Greater than 50 50% 67% 100% For adult patients whose baseline counts are WBC less than 3 x10 9 /L, ANC less than 1.5 x10 9 /L, or platelets less than 75 x10 9 /L, base dose adjustments on nadir counts and bone marrow biopsy cellularity at the time of the nadir as noted below, unless there is clear improvement in differentiation (percentage of mature granulocytes is higher and ANC is higher than at onset of that course) at the time of the next cycle, in which case continue the current dose. WBC or Platelet Nadir % decrease in counts from baseline Bone Marrow Biopsy Cellularity at Time of Nadir (%) 30 to 60 15 to 30 Less than 15 50 to 75 Greater than 75 % Dose in the Next Course 100 50 33 75 50 33 If a nadir as defined in the table above has occurred, give the next course 28 days after the start of the preceding course, provided that both the WBC and the platelet counts are greater than 25% above the nadir and rising. If a greater than 25% increase above the nadir is not seen by day 28, reassess counts every 7 days. If a 25% increase is not seen by day 42, reduce the scheduled dose by 50%. Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information. 2.5 Dosage Adjustment Based on Serum Electrolytes and Renal Toxicity If unexplained reductions in serum bicarbonate levels to less than 20 mEq/L occur, reduce the dosage by 50% for the next course. If unexplained elevations of BUN or serum creatinine occur, delay the next cycle until values return to normal or baseline and reduce the dose by 50% for the next course [ see Warnings and Precautions (5.4) ] . 2.6 Use in Geriatric Patients Azacitidine and its metabolites are 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, select the dose carefully and monitor renal function [ see Warnings and Precautions (5.4) and Use in Specific Populations (8.5) ] . 2.7 Preparation of Azacitidine for Injection Azacitidine for Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 The Azacitidine for Injection vial is single-dose and does not contain any preservatives. Discard unused portions of each vial properly [ see How Supplied/Storage and Handling (16) ] . Do not save any unused portions for later administration. 2.8 Instructions for Subcutaneous Administration Reconstitute Azacitidine for Injection aseptically with 4 mL Sterile Water for Injection to obtain a concentration of 25 mg/mL. Inject the diluent slowly into the vial. Vigorously shake or roll the vial until a uniform suspension is achieved. The suspension will be cloudy. Do not filter the suspension after reconstitution. Doing so could remove the active substance. Preparation for Immediate Subcutaneous Administration For doses requiring more than 1 vial, divide the dose equally between the syringes (e.g., dose 150 mg = 6 mL, 2 syringes with 3 mL in each syringe) and inject into two separate sites.

Dosage forms and strengths

For injection: 100 mg as a lyophilized powder in single-dose vial for reconstitution. For Injection: 100 mg as a lyophilized powder in single-dose vial for reconstitution ( 3 ).

Contraindications

Azacitidine for Injection is contraindicated in patients with advanced malignant hepatic tumors [ see Warnings and Precautions (5.3) ]. a known hypersensitivity to azacitidine. Advanced malignant hepatic tumors ( 4 ). Hypersensitivity to azacitidine ( 4 ).

Warnings and precautions

Risks of Substitution with Other Azacitidine Products : Do not substitute Azacitidine for Injection for oral azacitidine ( 2.1 , 5.1 ). Anemia, Neutropenia and Thrombocytopenia: Monitor complete blood counts (CBC) frequently ( 5.2 ). Hepatotoxicity : Patients with severe preexisting hepatic impairment are at higher risk for toxicity ( 5.3 ). Renal Toxicity : Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys ( 5.4 ). Tumor Lysis Syndrome : Azacitidine for Injection may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Assess baseline risk and monitor and treat as appropriate ( 5.5 ). Embryo-Fetal Toxicity : Can cause fetal harm. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception ( 5.6 , 8.1 , 8.3 ). 5.1 Risks of Substitution with Other Azacitidine Products Due to substantial differences in the pharmacokinetic parameters [ see Clinical Pharmacology ( 12.3 )], the recommended dose and schedule for Azacitidine for Injection are different from those of oral azacitidine products. Treatment of patients using Azacitidine for Injection at the recommended dosage of oral azacitidine may result in a fatal adverse reaction. Treatment of patients using oral azacitidine at the doses recommended for Azacitidine for Injection may not be effective. Do not substitute Azacitidine for Injection for oral azacitidine [ see Dosage and Administration (2.1) ]. 5.2 Anemia, Neutropenia and Thrombocytopenia Azacitidine for Injection causes anemia, neutropenia and thrombocytopenia. Monitor complete blood counts frequently for response and/or toxicity, at a minimum, prior to each dosing cycle. After administration of the recommended dosage for the first cycle, adjust dosage for subsequent cycles based on nadir counts and hematologic response [ see Dosage and Administration (2.4) ] . Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information. 5.3 Hepatic Toxicity in Patients with Severe Pre-existing Hepatic Impairment Because Azacitidine for Injection is potentially hepatotoxic in patients with severe pre-existing hepatic impairment, caution is needed in patients with liver disease. Patients with extensive tumor burden due to metastatic disease have been reported to experience progressive hepatic coma and death during azacitidine treatment, especially in such patients with baseline albumin less than 30 g/L. Azacitidine for Injection is contraindicated in patients with advanced malignant hepatic tumors [ see Contraindications (4) ] . Monitor liver chemistries prior to initiation of therapy and with each cycle. Safety and effectiveness of Azacitidine for Injection in patients with MDS and hepatic impairment have not been studied as these patients were excluded from the clinical trials. Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information. 5.4 Renal Toxicity Renal toxicity ranging from elevated serum creatinine to renal failure and death have been reported in patients treated with intravenous azacitidine in combination with other chemotherapeutic agents for non-MDS conditions. In addition, renal tubular acidosis, defined as a fall in serum bicarbonate to less than 20 mEq/L in association with an alkaline urine and hypokalemia (serum potassium less than 3 mEq/L) developed in 5 patients with CML (an unapproved use) treated with azacitidine and etoposide. Monitor serum creatinine and electrolytes prior to initiation of therapy and with each cycle. If unexplained reductions in serum bicarbonate less than 20 mEq/L or elevations of BUN or serum creatinine occur, reduce or hold the dose [ see Dosage and Administration (2.5) ] . Patients with renal impairment may be at increased risk for renal toxicity. Also, azacitidine and its metabolites are primarily excreted by the kidney. Therefore, monitor these patients closely for toxicity [see Dosage and Administration ( 2.5 , 2.6 )] . Patients with MDS and renal impairment were excluded from the clinical studies. Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information. 5.5 Tumor Lysis Syndrome Azacitidine for Injection may cause fatal or serious tumor lysis syndrome, including in patients with MDS. Tumor lysis syndrome may occur despite concomitant use of allopurinol. Assess baseline risk and monitor and treat as appropriate. 5.6 Embryo-Fetal Toxicity Based on the mechanism of action and findings in animals, Azacitidine for Injection can cause fetal harm when administered to a pregnant woman. In animal studies, azacitidine caused adverse developmental outcomes when administered to mice and rats at doses of 3 to 12 mg/m 2 and 6 mg/m 2 (approximately 4% to 16% and 8%) of the recommended human daily dose of 75 mg/m 2 , respectively. Advise pregnant women of the potential risk to a fetus . Advise females of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 6 months following the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 3 months following the last dose [see Use in Specific Populations ( 8.1 , 8.3 )] .

Side effects

The following clinically significant adverse reactions are described elsewhere in labeling: Anemia, Neutropenia and Thrombocytopenia [ see Warnings and Precautions (5.2) ] Hepatotoxicity in Patients with Severe Pre-existing Hepatic Impairment [ see Warnings and Precautions (5.3) ] Renal Toxicity [ see Warnings and Precautions (5.4) ] Tumor Lysis Syndrome [ see Warnings and Precautions (5.5) ] Most common adverse reactions (> 30%) in adult patients with MDS by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia and ecchymosis. Most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Actavis at 1-888-838-2872 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 data described below reflect exposure to azacitidine in 443 MDS patients from 4 clinical studies. Study 1 was a supportive-care controlled trial (subcutaneous administration), Studies 2 and 3 were single arm studies (one with subcutaneous administration and one with intravenous administration), and Study 4 was an international randomized trial (subcutaneous administration) [ see Clinical Studies (14) ] . In Studies 1, 2 and 3, a total of 268 patients were exposed to azacitidine, including 116 exposed for 6 cycles (approximately 6 months) or more and 60 exposed for greater than 12 cycles (approximately one year). Azacitidine was studied primarily in supportive-care controlled and uncontrolled trials (n=150 and n=118, respectively). The population in the subcutaneous studies (n=220) was 23 to 92 years old (mean 66.4 years), 68% male, and 94% white, and had MDS or AML. The population in the intravenous study (n=48) was 35 to 81 years old (mean 63.1 years), 65% male, and 100% white. Most patients received average daily doses between 50 and 100 mg/m 2 . In Study 4, a total of 175 patients with higher-risk MDS (primarily RAEB and RAEB-T subtypes) were exposed to azacitidine. Of these patients, 119 were exposed for 6 or more cycles, and 63 for at least 12 cycles. The mean age of this population was 68.1 years (ranging from 42 to 83 years), 74% were male, and 99% were white. Most patients received daily azacitidine doses of 75 mg/m 2 . Most Commonly Occurring Adverse Reactions (Subcutaneous or Intravenous Route) in Adult Patients with MDS : nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, ecchymosis. The most common adverse reactions by intravenous route also included petechiae, rigors, weakness and hypokalemia. Adverse Reactions Most Frequently (Greater Than 2%) Resulting in Clinical Intervention (Subcutaneous or Intravenous Route) in Adult Patients with MDS : Discontinuation : leukopenia, thrombocytopenia, neutropenia. Dose Held : leukopenia, neutropenia, thrombocytopenia, pyrexia, pneumonia, febrile neutropenia. Dose Reduced : leukopenia, neutropenia, thrombocytopenia. Table 1 presents adverse reactions occurring in at least 5% of patients treated with azacitidine (subcutaneous) in Studies 1 and 2. It is important to note that duration of exposure was longer for the azacitidine-treated group than for the observation group; patients received azacitidine for a mean of 11.4 months while mean time in the observation arm was 6.1 months. Table 1: Most Frequently Observed Adverse Reactions (Greater Than or Equal To 5% in All Subcutaneous Azacitidine-Treated Patients; Studies 1 and 2) Number (%) of Patients Body System Adverse Reaction a All Azacitidine b Observation c (N=220) (N=92) a Multiple terms of the same preferred terms for a patient are only counted once within each treatment group. b Includes adverse reactions from all patients exposed to azacitidine, including patients after crossing over from observations. c Includes adverse reactions from observation period only; excludes any adverse events after crossover to azacitidine.

Use in specific populations

Lactation: Advise not to breastfeed ( 8.2 ). Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information . 8.1 Pregnancy Risk Summary Based on its mechanism of action and findings in animals, Azacitidine for Injection can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no data on the use of azacitidine in pregnant women. Azacitidine was teratogenic and caused embryo-fetal lethality in animals at doses lower than the recommended human daily dose (see Data). Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage in the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Early embryotoxicity studies in mice revealed a 44% frequency of intrauterine embryonal death (increased resorption) after a single IP (intraperitoneal) injection of 6 mg/m 2 (approximately 8% of the recommended human daily dose on a mg/m 2 basis) azacitidine on gestation day 10. Developmental abnormalities in the brain have been detected in mice given azacitidine on or before gestation day 15 at doses of ~3 to 12 mg/m 2 (approximately 4% to 16% the recommended human daily dose on a mg/m 2 basis). In rats, azacitidine was clearly embryotoxic when given IP on gestation days 4 to 8 (postimplantation) at a dose of 6 mg/m 2 (approximately 8% of the recommended human daily dose on a mg/m 2 basis), although treatment in the preimplantation period (on gestation days 1 to 3) had no adverse effect on the embryos. Azacitidine caused multiple fetal abnormalities in rats after a single IP dose of 3 to 12 mg/m 2 (approximately 8% the recommended human daily dose on a mg/m 2 basis) given on gestation day 9, 10, 11 or 12. In this study azacitidine caused fetal death when administered at 3 to 12 mg/m 2 on gestation days 9 and 10; average live animals per litter was reduced to 9% of control at the highest dose on gestation day 9. Fetal anomalies included: CNS anomalies (exencephaly/encephalocele), limb anomalies (micromelia, club foot, syndactyly, oligodactyly), and others (micrognathia, gastroschisis, edema, and rib abnormalities). 8.2 Lactation Risk Summary There is no information on the presence of azacitidine or its metabolites in human milk, the effects on a breast-fed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for azacitidine in animal studies [ see Nonclinical Toxicology (13.1) ] and the potential for serious adverse reactions in a breastfeed child, advise women not to breastfeed during treatment with Azacitidine for Injection and for 1 week after the last dose. 8.3 Females and Males of Reproductive Potential Based on its mechanism of action and findings in animals, Azacitidine for Injection can cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating Azacitidine for Injection. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 6 months after the last dose [ see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3) ] . Males Based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 3 months after the last dose [ see Nonclinical Toxicology (13.1) ] . Infertility Based on animal data, azacitidine could have an effect on male or female fertility [ see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use Safety and effectiveness of Azacitidine for Injection in pediatric patients with MDS have not been established. Pediatric use information is approved for Celgene Corporation’s Vidaza ® (azacitidine for injection). However due to Celgene Corporation’s marketing exclusivity rights, this drug product is not labeled with that information. 8.5 Geriatric Use Of the total number of patients in Studies 1, 2 and 3, 62% were 65 years and older and 21% were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. In addition, there were no relevant differences in the frequency of adverse reactions observed in patients 65 years and older compared to younger patients. Of the 179 patients randomized to azacitidine in Study 4, 68% were 65 years and older and 21% were 75 years and older. Survival data for patients 65 years and older were consistent with overall survival results. The majority of adverse reactions occurred at similar frequencies in patients less than 65 years of age and patients 65 years of age and older. Elderly patients are more likely to have decreased renal function. Monitor renal function in these patients [ see Dosage and Administration (2.6) and Warnings and Precautions (5.4) ] .

Overdosage

One case of overdose with azacitidine was reported during clinical trials. A patient experienced diarrhea, nausea, and vomiting after receiving a single intravenous dose of approximately 290 mg/m 2 , almost 4 times the recommended starting dose. The events resolved without sequelae, and the correct dose was resumed the following day. In the event of overdosage, the patient should be monitored with appropriate blood counts and should receive supportive treatment, as necessary. There is no known specific antidote for Azacitidine for Injection overdosage.

Description

Azacitidine is a nucleoside metabolic inhibitor. The molecular formula is C 8 H 12 N 4 O 5 . The molecular weight is 244. Azacitidine is 4-amino-1-β-D-ribofuranosyl-s-triazin-2(1H)-one. The structural formula is as follows: Azacitidine is a white to almost white powder. Azacitidine was found to be insoluble in acetone, ethanol, and methyl ethyl ketone; slightly soluble in ethanol/water (50/50), propylene glycol, and polyethylene glycol; sparingly soluble in water, water saturated octanol, 5% dextrose in water, N-methyl-2-pyrrolidone, normal saline and 5% Tween 80 in water; and soluble in dimethylsulfoxide (DMSO). Azacitidine for Injection is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Each vial of Azacitidine for Injection contains 100 mg of azacitidine, 170 mg sucrose, monosodium phosphate monohydrate and disodium hydrogen phosphate, dihydrate as a sterile lyophilized powder. 9dca4f01-figure-01

How supplied

How Supplied Azacitidine for Injection is supplied as 100 mg of lyophilized powder in single-dose vials packaged in cartons of 1 vial (NDC 68001-313-56). Storage Store unreconstituted vials at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Discard unused portion. Handling and Disposal Azacitidine for Injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Sterile, Nonpyrogenic, Preservative-free. This vial stopper is not made with natural rubber latex.

Patient information

Hepatic Toxicity in Patients with Severe Pre-Existing Hepatic Impairment Instruct patients to inform their healthcare provider about any underlying liver disease [ see Warnings and Precautions (5.3) ]. Renal Toxicity Instruct patients to inform their healthcare provider about any underlying renal disease [ see Warnings and Precautions (5.4) ]. Embryo-Fetal Toxicity Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions (5.6) and Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 6 months after the last dose [ see Use in Specific Populations (8.3) ]. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with Azacitidine for Injection and for 3 months after the last dose [ see Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment with Azacitidine for Injection and for 1 week after the last dose [ see Use in Specific Populations (8.2) ]. Infertility Advise males and females of the potential for reduced fertility from Azacitidine for Injection [ see Use in Specific Populations (8.3) and Nonclinical Toxicology (13.1) ]. Manufactured In Romania By: Sindan Pharma SRL 11 Ion Mihalache Blvd. Bucharest 1, Romania 011171 For BluePoint Laboratories Rev. E 12/2024

Label text from the FDA structured product label by BluePoint Laboratories (revised May 26, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Azacitidine in 27 products

Azacitidine NDC products (27)

NDC	Strength & form	Labeler	Type
16729-306	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Accord Healthcare Inc.	ANDA
70121-1237	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Amneal Pharmaceuticals LLC	ANDA
60505-6271	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Apotex Corp	ANDA
72485-201	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Armas Pharmaceuticals Inc.	ANDA
68001-527	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	BluePoint Laboratories	ANDA
68001-620	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	BluePoint Laboratories.	ANDA
31722-365	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Camber Pharmaceuticals, Inc.	ANDA
72572-020	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Civica, Inc.	ANDA
75907-225	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Dr. Reddy's Laboratories Inc.	ANDA
43598-678	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Dr. Reddy's Laboratories Inc.	ANDA
43598-465	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Dr. Reddy's Laboratories Inc.	ANDA
43598-305	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Dr. Reddy's Laboratories Inc.	ANDA
55150-393	Azacitidine 100 mg/4mL Injection, Powder, Lyophilized, For Solution	Eugia US LLC	ANDA
63323-771	Azacitidine 100 mg/30mL Injection, Powder, Lyophilized, For Solution	Fresenius Kabi USA, LLC	ANDA
0143-9606	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Hikma Pharmaceuticals USA Inc.	ANDA
71288-153	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Meitheal Pharmaceuticals Inc.	ANDA
71288-115	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Meitheal Pharmaceuticals Inc.	ANDA
69539-112	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	MSN LABORATORIES PRIVATE LIMITED	ANDA
16714-927	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	NorthStar RxLLC	ANDA
43817-906	Azacitidine 100 mg/50mL Injection, Powder, Lyophilized, For Solution	Panacea Biotec Limited	ANDA
83774-102	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Pilnova Pharma Inc	ANDA
58458-002	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Reliance Life Sciences Private Limited	ANDA
0781-3491	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Sandoz Inc	ANDA
70069-857	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	Somerset Therapeutics LLC	ANDA
46014-7300	Azacitidine 300 mg/1 Tablet, Film Coated	Excella GmbH & Co. KG	DRUG FOR FURTHER PROCESSING
46014-7200	Azacitidine 200 mg/1 Tablet, Film Coated	Excella GmbH & Co. KG	DRUG FOR FURTHER PROCESSING
68001-313	Azacitidine 100 mg/1 Injection, Powder, Lyophilized, For Solution	BluePoint Laboratories	NDA

Azacitidine recalls

D-1334-2022 Aug 17, 2022 · Class III · Terminated
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
D-0575-2022 Mar 2, 2022 · Class III · Terminated
Failed stability specifications
D-0576-2022 Mar 2, 2022 · Class III · Terminated
Failed stability specifications
D-0122-2021 Dec 16, 2020 · Class II · Terminated
CGMP Deviations

Frequently asked questions

What is Azacitidine used for?

What are the side effects of Azacitidine?

Who makes Azacitidine?

Azacitidine is listed by 21 labelers in the FDA NDC directory, including Accord Healthcare Inc., Amneal Pharmaceuticals LLC, Apotex Corp, Armas Pharmaceuticals Inc..

Has Azacitidine been recalled?

The FDA enforcement database lists 4 recalls for Azacitidine, most recently D-1334-2022 (class iii): Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.