Home NDC 25021-244 BORTEZOMIB
Product NDC 25021-244
11-digit product format 250210244
Labeler code 25021
Product ID 25021-244_f083350e-ec7e-415d-85a3-1e48e414dbf2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name BORTEZOMIB
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Sagent Pharmaceuticals
Application ANDA208392
Marketing category ANDA
Marketing start 2022-05-01
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 A208392-001 BORTEZOMIB BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208392-001 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.
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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208392-001 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 A208392-001 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 A208392-001 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 A208392-001 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 A208392-001 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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208392-001 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 A208392-001 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 A208392-001 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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208392-001 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 A208392-001 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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208392-001 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 A208392-001 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 A208392-001 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 A208392-001 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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208392-001 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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-05-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208392-001 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 A208392-001 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 A208392-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 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 25021-244 BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SAGENT PHARMACEUTICALS] 1 Legacy NDC 20220503_3dd9cc46-9df3-406e-beb4-b6f45459b185.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25021-244-10 25021024410 1 VIAL in 1 CARTON (25021-244-10) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2022-05-01 0000-00-00 No No Current