vinorelbine

Generic: vinorelbine

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name vinorelbine
Generic Name vinorelbine
Labeler actavis pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

vinorelbine tartrate 10 mg/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-607
Product ID 45963-607_1a467892-817b-4ff8-a58e-b69e0c3462cc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078011
Listing Expiration 2026-12-31
Marketing Start 2015-03-01

Pharmacologic Class

Classes
vinca alkaloid [epc] vinca alkaloids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963607
Hyphenated Format 45963-607

Supplemental Identifiers

RxCUI
1729418 1729422
UPC
0345963607553
UNII
253GQW851Q

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vinorelbine (source: ndc)
Generic Name vinorelbine (source: ndc)
Application Number ANDA078011 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

45963-607-55 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE 45963-607-56 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

vinorelbine tartrate (10 mg/mL)

Linked Drug Pages (1)

Vinorelbine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1a467892-817b-4ff8-a58e-b69e0c3462cc", "openfda": {"upc": ["0345963607553"], "unii": ["253GQW851Q"], "rxcui": ["1729418", "1729422"], "spl_set_id": ["dd3dcc9a-e40c-4677-9ee6-f318e7c7d835"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-607-55", "marketing_start_date": "20150301"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-607-56", "marketing_start_date": "20150301"}], "brand_name": "Vinorelbine", "product_id": "45963-607_1a467892-817b-4ff8-a58e-b69e0c3462cc", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Vinca Alkaloid [EPC]", "Vinca Alkaloids [CS]"], "product_ndc": "45963-607", "generic_name": "Vinorelbine", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vinorelbine", "active_ingredients": [{"name": "VINORELBINE TARTRATE", "strength": "10 mg/mL"}], "application_number": "ANDA078011", "marketing_category": "ANDA", "marketing_start_date": "20150301", "listing_expiration_date": "20261231"}