NDC 72606-558

AZACITIDINE

Azacitidine

AZACITIDINE is a Intravenous; Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Celltrion Usa, Inc.. The primary component is Azacitidine.

Product ID72606-558_1542236d-9049-4a6b-8956-c53d38f8520c
NDC72606-558
Product TypeHuman Prescription Drug
Proprietary NameAZACITIDINE
Generic NameAzacitidine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2020-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA207518
Labeler NameCELLTRION USA, INC.
Substance NameAZACITIDINE
Active Ingredient Strength100 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72606-558-01

1 VIAL in 1 CARTON (72606-558-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
Marketing Start Date2020-01-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72606-558-01 [72606055801]

AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-01-06

Drug Details

Active Ingredients

IngredientStrength
AZACITIDINE100 mg/1

Pharmacological Class

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

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

NDCBrand NameGeneric Name
0143-9606AzacitidineAzacitidine
0591-2897AzacitidineAzacitidine
0781-3253Azacitidineazacitidine
0781-9253Azacitidineazacitidine
16714-578AzacitidineAzacitidine
16714-777AzacitidineAzacitidine
16714-927AzacitidineAzacitidine
16729-306AzacitidineAzacitidine
43598-143AzacitidineAzacitidine
43598-305AzacitidineAzacitidine
43598-465AzacitidineAzacitidine
43598-678AZACITIDINEAZACITIDINE
43817-906AzacitidineAzacitidine
51991-797AzacitidineAzacitidine
55150-393AZACITIDINEAZACITIDINE
68001-313AzacitidineAzacitidine
69097-368AzacitidineAzacitidine
72485-201AZACITIDINEAZACITIDINE
63323-771AzacitidineAzacitidine
63759-0003AZACITIDINEAZACITIDINE
64679-096AZACITIDINEAZACITIDINE
67457-254AzacitidineAzacitidine
72606-558AZACITIDINEAZACITIDINE
71288-115AzacitidineAzacitidine
59572-730ONUREGazacitidine
59572-740ONUREGazacitidine
59572-102VIDAZAazacitidine
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