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 ID: 45963-607_0cf4c381-64d8-4491-88bd-8cf3b7c61216
• NDC: 45963-607
• Product Type: Human Prescription Drug
• Proprietary Name: Vinorelbine
• Generic Name: Vinorelbine
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2015-03-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078011
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: VINORELBINE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Vinca Alkaloid [EPC],Vinca Alkaloids [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 45963-607-55

1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2015-03-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45963-607-55 [45963060755]

Vinorelbine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-01

NDC 45963-607-56 [45963060756]

Vinorelbine INJECTION, SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA078011
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-03-01

Drug Details

Active Ingredients

Ingredient	Strength
VINORELBINE	10 mg/mL

OpenFDA Data

• SPL SET ID: dd3dcc9a-e40c-4677-9ee6-f318e7c7d835
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • Q6C979R91Y
• 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"

NDC	Brand Name	Generic Name
25021-204	Vinorelbine	Vinorelbine
45963-607	Vinorelbine	Vinorelbine
50742-420	Vinorelbine	Vinorelbine
50742-427	Vinorelbine	Vinorelbine
61703-341	VINORELBINE	vinorelbine