NDC 72485-201

AZACITIDINE

Azacitidine

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

Product ID72485-201_5687ddbe-fed3-4a0d-a6cd-46d71dcaeb59
NDC72485-201
Product TypeHuman Prescription Drug
Proprietary NameAZACITIDINE
Generic NameAzacitidine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2018-09-10
Marketing CategoryANDA / ANDA
Application NumberANDA207518
Labeler NameArmas Pharmaceuticals 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 72485-201-01

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (72485-201-01)
Marketing Start Date2018-09-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72485-201-01 [72485020101]

AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-09-10

Drug Details

Active Ingredients

IngredientStrength
AZACITIDINE100 mg/1

OpenFDA Data

SPL SET ID:5c0a2d5f-8c34-4c04-8425-7543965cedd4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485246
  • Pharmacological Class

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