NDC 43598-678

AZACITIDINE AZACITIDINE

Azacitidine

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

Product ID43598-678_b7d42845-1888-66b9-77a0-c6f4902e21ac
NDC43598-678
Product TypeHuman Prescription Drug
Proprietary NameAZACITIDINE AZACITIDINE
Generic NameAzacitidine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2017-12-13
Marketing CategoryANDA / ANDA
Application NumberANDA207518
Labeler NameDr. Reddy's Laboratories Inc.
Substance NameAZACITIDINE
Active Ingredient Strength100 mg/1
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43598-678-11

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (43598-678-11)
Marketing Start Date2017-12-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43598-678-11 [43598067811]

AZACITIDINE AZACITIDINE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA207518
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-13

Drug Details

Active Ingredients

IngredientStrength
AZACITIDINE100 mg/1

OpenFDA Data

SPL SET ID:d38a1247-28c8-a911-e691-a983a2f9a6e3
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 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
    59572-730ONUREGazacitidine
    59572-740ONUREGazacitidine
    59572-102VIDAZAazacitidine
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