Home NDC 71288-118 Bortezomib
Product NDC 71288-118
11-digit product format 712880118
Labeler code 71288
Product ID 71288-118_27f6f56f-fefb-4caf-aee7-9e7e2a9c74f4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Bortezomib
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS; SUBCUTANEOUS
Labeler Meitheal Pharmaceuticals Inc.
Application ANDA212958
Marketing category ANDA
Marketing start 2022-07-26
Marketing end 2026-11-19
Substance BORTEZOMIB
Active strength 3.5 mg/1
Pharmacologic classes Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
NDC exclude flag No
Current FDA listing Yes 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 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212958-001 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 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 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 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212958-001 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 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212958-001 BORTEZOMIB 3.5MG/VIAL INJECTABLE / INTRAVENOUS, SUBCUTANEOUS AP 2022-07-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212958-001 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 A212958-001 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 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 71288-118-10 Bortezomib 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 6 71288-118-10 Bortezomib 1 in 1 VIAL, SINGLE-DOSE INJECTION, POWDER, LYOPHILIZED, 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71288-118 BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 2 package rows 20220729_322e315f-dd94-475f-94f4-4d86a7eb5590.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 · 2 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 71288-118-10 71288011810 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-118-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE 2022-07-26 2026-11-19 No No Current