Home NDC 0781-3258 bortezomib
Product NDC 0781-3258
11-digit product format 007813258
Labeler code 0781
Product ID 0781-3258_af4b1a62-3aa9-45bd-bc00-7f8276676cf2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bortezomib for injection
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Sandoz Inc
Application ANDA203654
Marketing category ANDA
Marketing start 2022-05-31
Marketing end 0000-00-00
Substance BORTEZOMIB
Active strength 4 mg/1
Pharmacologic classes Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A203654-001 BORTEZOMIB BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-07-26
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.
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 2026-08-18 06:07:40 2026-07 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 e64feba35796…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A203654-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-07-26 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-3258 BORTEZOMIB (BORTEZOMIB FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] 1 Legacy NDC 20220727_af4b1a62-3aa9-45bd-bc00-7f8276676cf2.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0781-3258-70 00781325870 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (0781-3258-70) 2022-05-31 0000-00-00 No No Current