NDC 67457-316

Decitabine

Decitabine

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

Product ID67457-316_236270ae-3387-4d6d-bbd9-f2000c4a72e0
NDC67457-316
Product TypeHuman Prescription Drug
Proprietary NameDecitabine
Generic NameDecitabine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-10-10
Marketing CategoryANDA / ANDA
Application NumberANDA204607
Labeler NameMylan Institutional LLC
Substance NameDECITABINE
Active Ingredient Strength50 mg/20mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-316-25

1 VIAL in 1 CARTON (67457-316-25) > 20 mL in 1 VIAL
Marketing Start Date2018-10-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-316-25 [67457031625]

Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204607
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-10-10

Drug Details

Active Ingredients

IngredientStrength
DECITABINE50 mg/20mL

OpenFDA Data

SPL SET ID:447a9fbd-106d-4ff6-8fd0-bb38a8c90e17
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636631
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Decitabine" or generic name "Decitabine"

    NDCBrand NameGeneric Name
    0143-9385decitabinedecitabine
    0781-3139DecitabineDecitabine
    0781-3296DecitabineDecitabine
    16714-749DecitabineDecitabine
    16714-928DecitabineDecitabine
    16729-224Decitabinedecitabine
    25021-231decitabinedecitabine
    42737-110DecitabineDecitabine
    43598-348DecitabineDecitabine
    43598-427DecitabineDecitabine
    47335-361decitabinedecitabine
    50742-430DECITABINEdecitabine
    55111-556DecitabineDecitabine
    55150-376DecitabineDecitabine
    68001-347DecitabineDecitabine
    69097-285DecitabineDecitabine
    67457-316DecitabineDecitabine
    64679-067DecitabineDecitabine
    68001-422DecitabineDecitabine
    69539-115DecitabineDecitabine
    63323-825DecitabineDecitabine
    68180-738decitabinedecitabine
    70121-1644DecitabineDecitabine
    72205-031DecitabineDecitabine
    72205-036DecitabineDecitabine
    75834-190DECITABINEDECITABINE
    72603-107DecitabineDecitabine
    59148-046Dacogendecitabine

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