BORTEZOMIB

Product NDC: 0409-1703
11-digit product format: 004091703
Labeler code: 0409
Product ID: 0409-1703_e7c31651-e301-43f9-bc81-e0fd5dcb828c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: BORTEZOMIB
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Hospira, Inc.
Application: NDA209191
Marketing category: NDA
Marketing start: 2022-05-16
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 42.

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
N209191-001	BORTEZOMIB	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-05-02
N209191-002	BORTEZOMIB	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N209191-001	AP
N209191-002	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.

Product history page 1 of 2 · 76 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
2026-08-18 06:07:40	2026-07	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-05-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS	AP	RLD, RS	2022-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209191-001	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209191-002	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD, RS	2022-05-02	`5c6f7cd8ea54…`
2019-12-13 00:20 UTC	2019-12	N209191-001	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209191-002	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-12-28	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209191-001	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-07-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209191-002	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-12-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209191-001	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-07-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N209191-002	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-12-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209191-001	BORTEZOMIB	2.5MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-07-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209191-002	BORTEZOMIB	1MG/VIAL	POWDER / INTRAVENOUS, SUBCUTANEOUS		RLD	2018-12-28	`8869cabd3fbd…`

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	N209191-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209191-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209191-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209191-002	AP	1	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209191-001	AP	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209191-002	AP	1	`a50c72e98297…`

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
2601542	Internal RxNorm lookup
2601544	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
9fdf6169-699f-40eb-bda1-760253062b3c	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	Strength	SPL version
0409-1703-01	BORTEZOMIB	1 in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, LYOPHILIZED,	1		3
0409-1703-01	BORTEZOMIB	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0409-1703-01	EA - Each	0409-1703	bb3beaf3-ee68-4507-a25f-427730537fa6	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0409-1703	BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.]	3	Current NDC, Legacy NDC, 2 package rows	20230308_9fdf6169-699f-40eb-bda1-760253062b3c.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BORTEZOMIB	BORTEZOMIB	Hospira, Inc.	9fdf6169-699f-40eb-bda1-760253062b3c	2023-02-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 209191 application number: NDA209191 ndc (product): 0409-1703

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
2601542	bortezomib 1 MG Injection	PSN	9fdf6169-699f-40eb-bda1-760253062b3c	3
2601544	bortezomib 2.5 MG Injection	PSN	9fdf6169-699f-40eb-bda1-760253062b3c	3
2601542	bortezomib 1 MG Injection	SCD	9fdf6169-699f-40eb-bda1-760253062b3c	3
2601544	bortezomib 2.5 MG Injection	SCD	9fdf6169-699f-40eb-bda1-760253062b3c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0409-1703-01	00409170301	1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1703-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2022-05-16	0000-00-00	No	No	Current