NDC 63759-0003

AZACITIDINE

Azacitidine For

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

Product ID63759-0003_aa9df125-bf25-4ac9-a339-a0e6638be29c
NDC63759-0003
Product TypeHuman Prescription Drug
Proprietary NameAZACITIDINE
Generic NameAzacitidine For
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2016-12-05
Marketing CategoryANDA / ANDA
Application NumberANDA207518
Labeler NameShilpa Medicare Limited
Substance NameAZACITIDINE
Active Ingredient Strength100 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63759-0003-1

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (63759-0003-1)
Marketing Start Date2016-12-05
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
AZACITIDINE100 mg/1

OpenFDA Data

SPL SET ID:722d67e6-df13-4ad1-9261-ca1daf722e9d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 485246
  • Pharmacological Class

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

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

    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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