NDC 51991-797

Azacitidine

Azacitidine

Azacitidine is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Breckenridge Pharmaceutical, Inc.. The primary component is Azacitidine.

• Product ID: 51991-797_14769175-5ce2-44fe-900a-a92aaab50b4f
• NDC: 51991-797
• Product Type: Human Prescription Drug
• Proprietary Name: Azacitidine
• Generic Name: Azacitidine
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2017-06-23
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207234
• Labeler Name: Breckenridge Pharmaceutical, Inc.
• Substance Name: AZACITIDINE
• Active Ingredient Strength: 100 mg/50mL
• Pharm Classes: Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 51991-797-98

1 VIAL, SINGLE-DOSE in 1 CARTON (51991-797-98) > 50 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-08-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51991-797-98 [51991079798]

Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA207234
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-08-07

Drug Details

Active Ingredients

Ingredient	Strength
AZACITIDINE	100 mg/50mL

OpenFDA Data

• SPL SET ID: 5facf2e9-f0d9-4be5-bcfa-5b85dd519c11
• Manufacturer:
  • Breckenridge Pharmaceutical, Inc.
• UNII:
  • M801H13NRU
• RxNorm Concept Unique ID - RxCUI:
  • 485246
• UPC Code:
  • 0351991797982

Pharmacological Class

• Nucleic Acid Synthesis Inhibitors [MoA]
• Nucleoside Metabolic Inhibitor [EPC]

NDC Crossover Matching brand name "Azacitidine" or generic name "Azacitidine"

NDC	Brand Name	Generic Name
0143-9606	Azacitidine	Azacitidine
0591-2897	Azacitidine	Azacitidine
0781-3253	Azacitidine	azacitidine
0781-9253	Azacitidine	azacitidine
16714-578	Azacitidine	Azacitidine
16714-777	Azacitidine	Azacitidine
16714-927	Azacitidine	Azacitidine
16729-306	Azacitidine	Azacitidine
43598-143	Azacitidine	Azacitidine
43598-305	Azacitidine	Azacitidine
43598-465	Azacitidine	Azacitidine
43598-678	AZACITIDINE	AZACITIDINE
43817-906	Azacitidine	Azacitidine
51991-797	Azacitidine	Azacitidine
55150-393	AZACITIDINE	AZACITIDINE
68001-313	Azacitidine	Azacitidine
69097-368	Azacitidine	Azacitidine
72485-201	AZACITIDINE	AZACITIDINE
63323-771	Azacitidine	Azacitidine
63759-0003	AZACITIDINE	AZACITIDINE
64679-096	AZACITIDINE	AZACITIDINE
67457-254	Azacitidine	Azacitidine
72606-558	AZACITIDINE	AZACITIDINE
71288-115	Azacitidine	Azacitidine
59572-730	ONUREG	azacitidine
59572-740	ONUREG	azacitidine
59572-102	VIDAZA	azacitidine