NDC 68083-386

Clofarabine

Clofarabine

Clofarabine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Clofarabine.

Product ID68083-386_0c7bd27b-9bb1-4591-ae6c-3739e52be020
NDC68083-386
Product TypeHuman Prescription Drug
Proprietary NameClofarabine
Generic NameClofarabine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-11-14
Marketing CategoryANDA / ANDA
Application NumberANDA207831
Labeler NameGland Pharma Limited
Substance NameCLOFARABINE
Active Ingredient Strength1 mg/mL
Pharm ClassesNucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-386-01

1 VIAL, SINGLE-DOSE in 1 CARTON (68083-386-01) > 20 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-11-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-386-01 [68083038601]

Clofarabine INJECTION
Marketing CategoryANDA
Application NumberANDA207831
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-14

Drug Details

Active Ingredients

IngredientStrength
CLOFARABINE1 mg/mL

OpenFDA Data

SPL SET ID:b7d3a96e-0280-4f14-b921-795996f75950
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 486419
  • UPC Code
  • 0368083386016
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0955-1746clofarabineclofarabine
    43598-309ClofarabineClofarabine
    49315-003CLOFARABINEclofarabine
    50742-512CLOFARABINEclofarabine
    55150-326CLOFARABINECLOFARABINE
    60505-6166Clofarabineclofarabine
    63323-572CLOFARABINEclofarabine
    67457-546clofarabineclofarabine
    68083-386ClofarabineClofarabine
    70121-1236ClofarabineClofarabine
    71288-128ClofarabineClofarabine
    72266-108CLOFARABINECLOFARABINE
    0024-5860Clolarclofarabine
    0024-5917Clolarclofarabine

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