NDC 45963-607

Vinorelbine

Vinorelbine

Vinorelbine is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Vinorelbine.

Product ID45963-607_0cf4c381-64d8-4491-88bd-8cf3b7c61216
NDC45963-607
Product TypeHuman Prescription Drug
Proprietary NameVinorelbine
Generic NameVinorelbine
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2015-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA078011
Labeler NameActavis Pharma, Inc.
Substance NameVINORELBINE
Active Ingredient Strength10 mg/mL
Pharm ClassesVinca Alkaloid [EPC],Vinca Alkaloids [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45963-607-55

1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) > 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2015-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45963-607-55 [45963060755]

Vinorelbine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078011
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-01

NDC 45963-607-56 [45963060756]

Vinorelbine INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078011
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-01

Drug Details

Active Ingredients

IngredientStrength
VINORELBINE10 mg/mL

OpenFDA Data

SPL SET ID:dd3dcc9a-e40c-4677-9ee6-f318e7c7d835
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1729422
  • 1729418
  • UPC Code
  • 0345963607553
  • 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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