NDC 67457-254

Azacitidine

Azacitidine

Azacitidine is a Intravenous; Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Azacitidine.

Product ID67457-254_7739eb5a-5c1f-4527-9e0a-ca934a461749
NDC67457-254
Product TypeHuman Prescription Drug
Proprietary NameAzacitidine
Generic NameAzacitidine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS; SUBCUTANEOUS
Marketing Start Date2016-05-23
Marketing CategoryANDA / ANDA
Application NumberANDA204949
Labeler NameMylan Institutional LLC
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 67457-254-30

1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (67457-254-30)
Marketing Start Date2016-05-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-254-30 [67457025430]

Azacitidine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204949
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-23

Drug Details

Active Ingredients

IngredientStrength
AZACITIDINE100 mg/1

OpenFDA Data

SPL SET ID:113af8ed-ac29-41a9-bbbb-5d03d654846b
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"

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.