NDC 69097-285

Decitabine

Decitabine

Decitabine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Cipla Usa Inc.. The primary component is Decitabine.

Product ID69097-285_09f6cad4-9a16-4266-bedb-72fc6194328a
NDC69097-285
Product TypeHuman Prescription Drug
Proprietary NameDecitabine
Generic NameDecitabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA208601
Labeler NameCipla USA 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 69097-285-37

1 VIAL, SINGLE-USE in 1 CARTON (69097-285-37) > 10 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2017-11-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69097-285-37 [69097028537]

Decitabine INJECTION
Marketing CategoryANDA
Application NumberANDA208601
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-16

Drug Details

Active Ingredients

IngredientStrength
DECITABINE50 mg/10mL

OpenFDA Data

SPL SET ID:18651e4f-398c-4889-b199-b92b2bd49568
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636631
  • UPC Code
  • 0369097285371
  • 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

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