BENDAMUSTINE HYDROCHLORIDE

Product NDC: 42367-520
11-digit product format: 423670520
Labeler code: 42367
Product ID: 42367-520_d59adc7a-6b2a-45ec-961b-d8a99f6d3933
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: bendamustine hydrochloride
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Eagle Pharmaceuticals, Inc
Application: NDA205580
Marketing category: NDA
Marketing start: 2018-05-15
Marketing end: 2020-09-30
Substance: BENDAMUSTINE HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	42367-520		D	Discontinued by firm		2026-08-10
excluded package	package	42367-520	42367-520-25	D	Discontinued by firm		2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	42367-520-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	42367-520-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42367-520-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42367-520-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42367-520-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42367-520-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42367-520-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42367-520-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42367-520-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42367-520-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42367-520-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42367-520-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N205580-001	BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N205580-001	AP

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205580-001	8791270	2026-01-12	U-1971	Drug product	2018-08-01
N205580-001	8791270	2026-01-12	U-1972	Drug product	2018-08-01
N205580-001	10010533	2031-01-28		Drug product	2018-07-03
N205580-001	11103483	2031-01-28	U-1971	Drug product	2021-08-31
N205580-001	11103483	2031-01-28	U-1972	Drug product	2021-08-31
N205580-001	11844783	2031-01-28	U-1542		2023-12-19
N205580-001	11844783	2031-01-28	U-1971		2023-12-19
N205580-001	11844783	2031-01-28	U-1972		2023-12-19
N205580-001	11872214	2031-01-28		Drug product	2024-01-16
N205580-001	12138248	2031-01-28		Drug product	2025-01-27
N205580-001	12350257	2031-01-28	U-1542	Drug product	2025-07-14
N205580-001	12350257	2031-01-28	U-1971	Drug product	2025-07-14
N205580-001	12350257	2031-01-28	U-1972	Drug product	2025-07-14
N205580-001	9265831	2031-01-28		Drug product	2018-08-01
N205580-001	9572796	2031-01-28	U-1971	Drug product	2018-08-01
N205580-001	9572796	2031-01-28	U-1972	Drug product	2018-08-01
N205580-001	9572797	2031-01-28	U-1971		2018-08-01
N205580-001	9572797	2031-01-28	U-1972		2018-08-01
N205580-001	8609707	2031-08-11	U-1971	Drug product	2018-08-01
N205580-001	8609707	2031-08-11	U-1972	Drug product	2018-08-01

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 · 41 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	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	2018-05-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N205580-001	BELRAPZO	100MG/4ML (25MG/ML)	SOLUTION / IV (INFUSION)		RLD, RS	2018-05-15	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205580-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205580-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205580-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205580-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205580-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205580-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205580-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N205580-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N205580-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N205580-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N205580-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N205580-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N205580-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N205580-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N205580-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N205580-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N205580-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N205580-001	AP	1	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N205580-001	AP	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 562 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	N205580-001	8791270	2026-01-12	U-1971	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	8791270	2026-01-12	U-1972	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	10010533	2031-01-28		Drug product	2018-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11103483	2031-01-28	U-1971	Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11103483	2031-01-28	U-1972	Drug product	2021-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11844783	2031-01-28	U-1542		2023-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11844783	2031-01-28	U-1971		2023-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11844783	2031-01-28	U-1972		2023-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	11872214	2031-01-28		Drug product	2024-01-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12138248	2031-01-28		Drug product	2025-01-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12350257	2031-01-28	U-1542	Drug product	2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12350257	2031-01-28	U-1971	Drug product	2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	12350257	2031-01-28	U-1972	Drug product	2025-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9265831	2031-01-28		Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572796	2031-01-28	U-1971	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572796	2031-01-28	U-1972	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572797	2031-01-28	U-1972		2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	9572797	2031-01-28	U-1971		2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	8609707	2031-08-11	U-1971	Drug product	2018-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205580-001	8609707	2031-08-11	U-1972	Drug product	2018-08-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8791270	2026-01-12	U-1971	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8791270	2026-01-12	U-1972	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	10010533	2031-01-28		Drug product	2018-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11103483	2031-01-28	U-1971	Drug product	2021-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11103483	2031-01-28	U-1972	Drug product	2021-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11844783	2031-01-28	U-1542		2023-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11844783	2031-01-28	U-1971		2023-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11844783	2031-01-28	U-1972		2023-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	11872214	2031-01-28		Drug product	2024-01-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12138248	2031-01-28		Drug product	2025-01-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12350257	2031-01-28	U-1542	Drug product	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12350257	2031-01-28	U-1971	Drug product	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	12350257	2031-01-28	U-1972	Drug product	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9265831	2031-01-28		Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572796	2031-01-28	U-1971	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572796	2031-01-28	U-1972	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572797	2031-01-28	U-1972		2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	9572797	2031-01-28	U-1971		2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8609707	2031-08-11	U-1971	Drug product	2018-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205580-001	8609707	2031-08-11	U-1972	Drug product	2018-08-01	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-01-26 05:58 UTC	2023-01	N205580-001	ODE*	2022-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N205580-001	ODE*	2022-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N205580-001	ODE*	2022-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N205580-001	ODE*	2022-12-07	`e64feba35796…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42367-520-25	ML - Milliliter	42367-520	41a636e2-c5f3-4a3e-8aaa-68499e07bcde	1	2018-08-13

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
BELRAPZO	BENDAMUSTINE HYDROCHLORIDE	Eagle Pharmaceuticals, Inc	9759a4ae-82ca-40cf-9c02-e1cadb21cbdc	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205580 application number: NDA205580