BORTEZOMIB

Product NDC: 55150-337
11-digit product format: 551500337
Labeler code: 55150
Product ID: 55150-337_107c9155-9130-4202-b2e4-4c7732561420
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BORTEZOMIB
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Eugia US LLC
Application: ANDA212825
Marketing category: ANDA
Marketing start: 2022-05-02
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 44.

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
A212825-001	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
A212825-001	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
2026-10-15 13:18:30	2026-09	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212825-001	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	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212825-001	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	A212825-001	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	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	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	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212825-001	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	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212825-001	BORTEZOMIB	3.5MG/VIAL	INJECTABLE / INTRAVENOUS, SUBCUTANEOUS	AP	2022-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212825-001	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	A212825-001	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	A212825-001	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
2026-10-15 13:18:30	2026-09	A212825-001	AP	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A212825-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212825-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212825-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212825-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212825-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212825-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212825-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212825-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212825-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212825-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212825-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212825-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212825-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212825-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212825-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212825-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212825-001	AP	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212825-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212825-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212825-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212825-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212825-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212825-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212825-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212825-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212825-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212825-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212825-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212825-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212825-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212825-001	AP	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76c7c3a5-fd2f-403f-85fd-65a64538eee7	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
55150-337-01	BORTEZOMIB	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1	3
55150-337-01	BORTEZOMIB	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	3
55150-337-02	BORTEZOMIB	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1	1
55150-337-02	BORTEZOMIB	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55150-337-01	EA - Each	55150-337	d603370e-e5b0-45a5-bc14-7154e28edc32	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55150-337	BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241208_76c7c3a5-fd2f-403f-85fd-65a64538eee7.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BORTEZOMIB	BORTEZOMIB	Eugia US LLC	ed526447-a4fe-403b-8f08-21ce1b2fa8b7	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212825 application number: ANDA212825 ndc (product): 55150-337
BORTEZOMIB	BORTEZOMIB	Eugia US LLC	76c7c3a5-fd2f-403f-85fd-65a64538eee7	2023-10-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212825 application number: ANDA212825 ndc (product): 55150-337

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
402243	bortezomib 3.5 MG Injection	PSN	76c7c3a5-fd2f-403f-85fd-65a64538eee7	3
402243	bortezomib 3.5 MG Injection	SCD	76c7c3a5-fd2f-403f-85fd-65a64538eee7	3
402243	bortezomib 3.5 MG Injection	PSN	ed526447-a4fe-403b-8f08-21ce1b2fa8b7	1
402243	bortezomib 3.5 MG Injection	SCD	ed526447-a4fe-403b-8f08-21ce1b2fa8b7	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55150-337-01	55150033701	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2022-05-02	0000-00-00	No	No	Current
55150-337-02	55150033702	1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2022-05-02		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BORTEZOMIB	Eugia US LLC \| EUGIA Pharma Specialities Limited	2025-12-23	Human Prescription Drug Label	1
BORTEZOMIB	Eugia US LLC \| EUGIA Pharma Specialities Limited	2023-10-20	Human Prescription Drug Label	3