Home NDC 63323-278-10 Vinblastine Sulfate
Product NDC 63323-278
Requested package NDC 63323-278-10
11-digit product format 633230278
Labeler code 63323
Product ID 63323-278_a6f97b09-27c2-4686-b89b-76dc77f44f50
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VINBLASTINE SULFATE
Dosage form INJECTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA089515
Marketing category ANDA
Marketing start 2000-07-12
Substance VINBLASTINE SULFATE
Active strength 1 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 43 .
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 A089515-001 VINBLASTINE SULFATE VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29
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 · 43 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 2026-09-14 22:38:34 2026-08 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A089515-001 VINBLASTINE SULFATE 1MG/ML INJECTABLE / INJECTION RS 1987-04-29 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Vinblastine Sulfate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VINBLASTINE SULFATE 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N00W22YO2B Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 239178 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 63323-278-10 Vinblastine Sulfate 1 in 1 BOX INJECTION 1 5 63323-278-10 Vinblastine Sulfate 10 mL in 1 VIAL, MULTI-DOSE INJECTION 10 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-278 VINBLASTINE SULFATE INJECTION [FRESENIUS KABI USA, LLC] 5 Current NDC, Legacy NDC, 2 package rows 20250429_f073b58e-56d6-4c8d-a2ce-b37719402d77.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 63323-278-10 63323027810 1 VIAL, MULTI-DOSE in 1 BOX (63323-278-10) / 10 mL in 1 VIAL, MULTI-DOSE 2000-07-12 0000-00-00 No No Current