NDC 0781-3296

Decitabine

Decitabine

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

Product ID0781-3296_040f064f-e4bf-4a22-a7ad-777cd66e2050
NDC0781-3296
Product TypeHuman Prescription Drug
Proprietary NameDecitabine
Generic NameDecitabine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA212265
Labeler NameSandoz Inc
Substance NameDECITABINE
Active Ingredient Strength50 mg/10mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-3296-80

1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3296-80) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2020-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3296-80 [00781329680]

Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA212265
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-01

Drug Details

Active Ingredients

IngredientStrength
DECITABINE50 mg/10mL

OpenFDA Data

SPL SET ID:c75493fd-b64d-4ed4-8a5c-b78bad5dbc3d
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.