NDC 50742-427

Vinorelbine

Vinorelbine

Vinorelbine is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Ingenus Pharmaceuticals, Llc. The primary component is Vinorelbine Tartrate.

Product ID50742-427_01aeb6d9-1879-4f03-a988-abbfd50b6d37
NDC50742-427
Product TypeHuman Prescription Drug
Proprietary NameVinorelbine
Generic NameVinorelbine
Dosage FormInjection
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-08-08
Marketing CategoryANDA / ANDA
Application NumberANDA208997
Labeler NameIngenus Pharmaceuticals, LLC
Substance NameVINORELBINE TARTRATE
Active Ingredient Strength50 mg/5mL
Pharm ClassesVinca Alkaloid [EPC],Vinca Alkaloids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 50742-427-05

1 VIAL, SINGLE-USE in 1 CARTON (50742-427-05) > 5 mL in 1 VIAL, SINGLE-USE
Marketing Start Date2019-08-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50742-427-05 [50742042705]

Vinorelbine INJECTION
Marketing CategoryANDA
Application NumberANDA208997
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-08-08

Drug Details

Active Ingredients

IngredientStrength
VINORELBINE TARTRATE50 mg/5mL

OpenFDA Data

SPL SET ID:6a16e044-7d0e-44bd-8e7e-588a5063935f
Manufacturer
UNII
UPC Code
  • 0350742427055
  • 0350742420018

    • Pharmacological Class

    • Vinca Alkaloid [EPC]
    • Vinca Alkaloids [CS]

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

    NDCBrand NameGeneric Name
    25021-204VinorelbineVinorelbine
    45963-607VinorelbineVinorelbine
    50742-420VinorelbineVinorelbine
    50742-427VinorelbineVinorelbine
    61703-341VINORELBINEvinorelbine
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