Home NDC 70511-162 Bortezomib
Product NDC 70511-162
11-digit product format 705110162
Labeler code 70511
Product ID 70511-162_2cc294fe-75e3-4ed9-8259-c6e5bc5e8286
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name bortezomib
Dosage form INJECTION
Route INTRAVENOUS
Labeler MAIA Pharmaceuticals, Inc.
Application NDA215331
Marketing category NDA
Marketing start 2022-08-10
Substance BORTEZOMIB
Active strength 2.5 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 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N215331-001 BORTEZOMIB BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 N215331-002 BORTEZOMIB BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215331-001 11679119 2042-09-23 U-3632 2023-06-27 N215331-001 11679119 2042-09-23 U-3633 2023-06-27 N215331-001 11752164 2042-09-23 U-3632 2023-09-28 N215331-001 11752164 2042-09-23 U-3633 2023-09-28 N215331-001 12005069 2042-09-23 Drug product 2024-06-20 N215331-002 11679119 2042-09-23 U-3632 2023-06-27 N215331-002 11679119 2042-09-23 U-3633 2023-06-27 N215331-002 11752164 2042-09-23 U-3632 2023-09-28 N215331-002 11752164 2042-09-23 U-3633 2023-09-28 N215331-002 12005069 2042-09-23 Drug product 2024-06-20
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.
Product history page 1 of 2 · 54 observed 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 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215331-001 BORTEZOMIB 3.5MG/3.5ML (1MG/ML) SOLUTION / INTRAVENOUS RLD 2022-07-27 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215331-002 BORTEZOMIB 3.5MG/1.4ML (2.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2022-07-27 a67488948f0b…
Observed Orange Book patent history# Patent history page 1 of 5 · 190 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N215331-001 11679119 2042-09-23 U-3632 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-001 11679119 2042-09-23 U-3633 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-001 11752164 2042-09-23 U-3632 2023-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-001 11752164 2042-09-23 U-3633 2023-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-001 12005069 2042-09-23 Drug product 2024-06-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-002 11679119 2042-09-23 U-3632 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-002 11679119 2042-09-23 U-3633 2023-06-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-002 11752164 2042-09-23 U-3632 2023-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-002 11752164 2042-09-23 U-3633 2023-09-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215331-002 12005069 2042-09-23 Drug product 2024-06-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-001 11679119 2042-09-23 U-3632 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-001 11679119 2042-09-23 U-3633 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-001 11752164 2042-09-23 U-3632 2023-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-001 11752164 2042-09-23 U-3633 2023-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-001 12005069 2042-09-23 Drug product 2024-06-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-002 11679119 2042-09-23 U-3632 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-002 11679119 2042-09-23 U-3633 2023-06-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-002 11752164 2042-09-23 U-3632 2023-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-002 11752164 2042-09-23 U-3633 2023-09-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215331-002 12005069 2042-09-23 Drug product 2024-06-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215331-001 11679119 2042-09-23 U-3632 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-001 11679119 2042-09-23 U-3633 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-001 11752164 2042-09-23 U-3632 2023-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-001 11752164 2042-09-23 U-3633 2023-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-001 12005069 2042-09-23 Drug product 2024-06-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-002 11679119 2042-09-23 U-3632 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-002 11679119 2042-09-23 U-3633 2023-06-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-002 11752164 2042-09-23 U-3632 2023-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-002 11752164 2042-09-23 U-3633 2023-09-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215331-002 12005069 2042-09-23 Drug product 2024-06-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-001 11679119 2042-09-23 U-3632 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-001 11679119 2042-09-23 U-3633 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-001 11752164 2042-09-23 U-3632 2023-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-001 11752164 2042-09-23 U-3633 2023-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-001 12005069 2042-09-23 Drug product 2024-06-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-002 11679119 2042-09-23 U-3632 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-002 11679119 2042-09-23 U-3633 2023-06-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-002 11752164 2042-09-23 U-3632 2023-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-002 11752164 2042-09-23 U-3633 2023-09-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215331-002 12005069 2042-09-23 Drug product 2024-06-20 fd3edfee7708…
Additional Listing Data#
Finished product Yes
Brand name base Bortezomib
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BORTEZOMIB 2.5 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2608948 Internal RxNorm lookup 2608952 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 70511-162-02 Bortezomib 1 in 1 VIAL, SINGLE-DOSE INJECTION 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70511-162 BORTEZOMIB INJECTION [MAIA PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 1 package rows 20220812_c40e6a28-d577-43d4-bca6-bef28da1d580.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 70511-162-02 70511016202 1 INJECTION in 1 VIAL, SINGLE-DOSE (70511-162-02) 1 injection 2022-08-11 0000-00-00 No No Current