Home NDC 10019-991-01 BORTEZOMIB
Product NDC 10019-991
Requested package NDC 10019-991-01
11-digit product format 100190991
Labeler code 10019
Product ID 10019-991_d8d0b49f-bf01-47f6-9e7a-40f203f95f28
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bortezomib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Baxter Healthcare Corporation
Application ANDA213823
Marketing category ANDA
Marketing start 2022-05-02
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 2023-12-31
Current FDA listing Historical FDA.report record 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 A213823-001 BORTEZOMIB BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-05-02
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 2026-02-19 14:30 UTC 2026-02 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A213823-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS 2022-05-02 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 10019-991 BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BAXTER HEALTHCARE CORPORATION] 7 Legacy NDC 20250209_5ba41024-53f5-40a1-88c7-591d588599b7.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 10019-991-01 10019099101 1 VIAL, SINGLE-DOSE in 1 CARTON (10019-991-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2022-05-02 0000-00-00 No No Current