Carmustine

Product NDC: 70860-223
11-digit product format: 708600223
Labeler code: 70860
Product ID: 70860-223_86b3d115-2f9c-44bb-81be-7a7eafaac9e3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: carmustine
Dosage form: KIT
Route: INTRAVENOUS
Labeler: Athenex Pharmaceutical Division, LLC.
Application: ANDA211011
Marketing category: ANDA
Marketing start: 2022-07-11
Marketing end: 0000-00-00
Active strength: 0
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	70860-223		D	Discontinued by firm		2026-08-07
excluded package	package	70860-223	70860-223-61	D	Discontinued by firm		2026-08-07

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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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	70860-223-61	`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
A211011-001	CARMUSTINE	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION			2022-06-21

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
2026-02-19 14:30 UTC	2026-02	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION	AP	2022-06-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211011-001	CARMUSTINE	100MG/VIAL	INJECTABLE / INJECTION		2022-06-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-02-18 07:12 UTC	2024-02	A211011-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211011-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211011-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211011-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211011-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211011-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211011-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211011-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211011-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211011-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211011-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211011-001	AP	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70860-223-61	2024-02-27	C162847	48780-1	1030e365-1cd1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CARMUSTINE FOR INJECTION safely and effectively. See full prescribing information for CARMUSTINE FOR INJECTION. CARMUSTINE for injection, for intravenous use Initial U.S. Approval: 1977
70860-223-61	2024-01-30	C162847	48780-1	1030e365-1cd1-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use CARMUSTINE FOR INJECTION safely and effectively. See full prescribing information for CARMUSTINE FOR INJECTION. CARMUSTINE for injection, for intravenous use Initial U.S. Approval: 1977

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70860-223-61	EA - Each	70860-223	47614571-ea54-4395-88e9-05b17c9b23b6	1	2023-06-06

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U68WG3173Y	CARMUSTINE	154-93-8	carmustine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70860-223-61	70860022361	1 KIT in 1 CARTON (70860-223-61) * 30 mL in 1 VIAL, SINGLE-DOSE (70860-221-30) * 3 mL in 1 VIAL (70860-222-03)	1 kit	2022-07-11	0000-00-00	No	No	Current