Home NDC 0143-9098 bortezomib
Product NDC 0143-9098
11-digit product format 001439098
Labeler code 0143
Product ID 0143-9098_e673dbf4-9d4e-4665-ac36-81c6537044fc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bortezomib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA215011
Marketing category ANDA
Marketing start 2022-07-27
Substance BORTEZOMIB
Active strength 3.5 mg/1
Pharmacologic classes Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
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 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 A215011-001 BORTEZOMIB BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215011-001 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 2026-08-18 06:07:40 2026-07 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215011-001 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 A215011-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base bortezomib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BORTEZOMIB 3.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 69G8BD63PP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 402243 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 0143-9098-01 bortezomib 1 in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 1 2 0143-9098-01 bortezomib 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0143-9098 BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 2 package rows 20220728_854be921-5fd9-482a-8432-a0c0241625f8.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 Units Marketing start Marketing end Sample Exclude flag Status 0143-9098-01 00143909801 1 VIAL in 1 CARTON (0143-9098-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL 1 vial 2022-07-27 0000-00-00 No No Current