Home NDC 45963-607 Vinorelbine
Product NDC 45963-607
11-digit product format 459630607
Labeler code 45963
Product ID 45963-607_1a467892-817b-4ff8-a58e-b69e0c3462cc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Vinorelbine
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Actavis Pharma, Inc.
Application ANDA078011
Marketing category ANDA
Marketing start 2015-03-01
Substance VINORELBINE TARTRATE
Active strength 10 mg/mL
Pharmacologic classes Vinca Alkaloid [EPC], Vinca Alkaloids [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078011-001 VINORELBINE TARTRATE VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078011-001 AP
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078011-001 VINORELBINE TARTRATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2009-07-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Vinorelbine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VINORELBINE TARTRATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 253GQW851Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1729418 Internal RxNorm lookup 1729422 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 45963-607-55 Vinorelbine 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 1 31 45963-607-55 Vinorelbine 1 in 1 CARTON INJECTION, SOLUTION 1 31 45963-607-56 Vinorelbine 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 31 45963-607-56 Vinorelbine 1 in 1 CARTON INJECTION, SOLUTION 1 31
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 45963-607 VINORELBINE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] 31 Current NDC, Legacy NDC, 4 package rows 20230613_dd3dcc9a-e40c-4677-9ee6-f318e7c7d835.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 45963-607-55 45963060755 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-55) / 1 mL in 1 VIAL, SINGLE-DOSE 2015-03-01 0000-00-00 No No Current 45963-607-56 45963060756 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-607-56) / 5 mL in 1 VIAL, SINGLE-DOSE 2015-03-01 0000-00-00 No No Current