NDC 68001-347

Decitabine

Decitabine

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

Product ID68001-347_fca8fac8-8d77-4e3f-8e55-03bdbbe88ee3
NDC68001-347
Product TypeHuman Prescription Drug
Proprietary NameDecitabine
Generic NameDecitabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-16
Marketing CategoryANDA / ANDA
Application NumberANDA208601
Labeler NameBluePoint Laboratories
Substance NameDECITABINE
Active Ingredient Strength50 mg/10mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68001-347-36

1 VIAL, SINGLE-USE in 1 CARTON (68001-347-36) > 10 mL in 1 VIAL, SINGLE-USE (68001-347-28)
Marketing Start Date2018-04-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68001-347-36 [68001034736]

Decitabine INJECTION
Marketing CategoryANDA
Application NumberANDA208601
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-04-30

NDC 68001-347-28 [68001034728]

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:bc5e093a-e841-42f0-b42a-cb6ba73a8679
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636631
    • UPC Code
  • 0368001347280

    • 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 "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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