Bortezomib

Product NDC: 50742-484
11-digit product format: 507420484
Labeler code: 50742
Product ID: 50742-484_125ff955-0078-4a7e-a4d9-80739bcf302c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Bortezomib
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Ingenus Pharmaceuticals, LLC
Application: ANDA210824
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50742-484		D	Discontinued by firm		2026-08-17
excluded package	package	50742-484	50742-484-01	D	Discontinued by firm		2026-08-17

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
A210824-001	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
A210824-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210824-001	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	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210824-001	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	A210824-001	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	A210824-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210824-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210824-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210824-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210824-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210824-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210824-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210824-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210824-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210824-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210824-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210824-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210824-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210824-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210824-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210824-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210824-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210824-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210824-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210824-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210824-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210824-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210824-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210824-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210824-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210824-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210824-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210824-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210824-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210824-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210824-001	AP	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b069d653-565d-b331-cf82-116aa266aee9	Product name	4	20260317
987023d7-918d-4465-be3c-f3f8f784679b	Product name	1	20250318
2cff6375-aa9a-4194-a1db-33f6ed6564f1	Product name	1	20230322
f8ade071-6be1-4cb3-a390-e8ba41353f9b	Product name	1	20230322
c3c5823c-3bc3-46c2-bc6a-295b30affa78	Product name	1	20230113
6429b384-c989-4e27-bc69-c5e1c7dc2e31	Product name	1	20200304
71c1111b-030c-4ada-94cb-bf623cfad8ec	Product name	1	20180108

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50742-484-01	EA - Each	50742-484	834c6450-40e4-468a-aea5-39aa61f61c40	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50742-484	BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [INGENUS PHARMACEUTICALS, LLC]	3	Legacy NDC	20231229_c9bf8425-afa5-4171-b114-d83acb6d526d.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BORTEZOMIB	BORTEZOMIB	Sagent Pharmaceuticals	945fbaf0-7a79-4676-aa90-e9a213c0654f	2025-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210824 application number: ANDA210824
Bortezomib	BORTEZOMIB	BluePoint Laboratories	12500f21-8e2f-4bcd-861e-4dfca843da2e	2022-05-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210824 application number: ANDA210824
Bortezomib	BORTEZOMIB	Qilu Pharmaceutical Co., Ltd.	aef02171-bf8a-43ad-b40c-7642623f9802	2022-05-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210824 application number: ANDA210824

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
69G8BD63PP	BORTEZOMIB	179324-69-7	BORTEZOMIB

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50742-484-01	50742048401	1 VIAL in 1 CARTON (50742-484-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL	1 vial	2022-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bortezomib	Ingenus Pharmaceuticals, LLC \| Qilu Pharmaceutical (Hainan) Co., Ltd.	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	4