NDC 16714-928

Decitabine

Decitabine

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

Product ID16714-928_1e082142-927d-9418-2ec3-03b934e532c5
NDC16714-928
Product TypeHuman Prescription Drug
Proprietary NameDecitabine
Generic NameDecitabine
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-02-18
Marketing CategoryANDA / ANDA
Application NumberANDA203131
Labeler NameNorthstar Rx LLC
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 16714-928-01

1 VIAL, SINGLE-DOSE in 1 CARTON (16714-928-01) > 10 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2019-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-928-01 [16714092801]

Decitabine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA203131
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-18

Drug Details

Active Ingredients

IngredientStrength
DECITABINE50 mg/10mL

OpenFDA Data

SPL SET ID:4730a57f-d04f-bcc3-ef35-1bfdd0284b4d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 636631
  • UPC Code
  • 0316714928012
  • 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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