Temozolomide

Product NDC: 43975-252
11-digit product format: 439750252
Labeler code: 43975
Product ID: 43975-252_1d3dfef5-79f0-4761-b533-be6e9358eab1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA203490
Marketing category: ANDA
Marketing start: 2016-07-13
Marketing end: 0000-00-00
Substance: TEMOZOLOMIDE
Active strength: 5 mg/1
Pharmacologic classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43975-252		D	Discontinued by firm	2026-10-05
excluded package	package	43975-252	43975-252-05	D	Discontinued by firm	2026-10-05
excluded package	package	43975-252	43975-252-14	D	Discontinued by firm	2026-10-05

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 · 36 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	43975-252-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43975-252-05	`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	43975-252-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43975-252-05	`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	43975-252-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43975-252-05	`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	43975-252-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43975-252-05	`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	43975-252-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43975-252-05	`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	43975-252-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43975-252-05	`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	43975-252-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43975-252-05	`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	43975-252-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43975-252-05	`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	43975-252-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43975-252-05	`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	43975-252-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43975-252-05	`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	43975-252-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43975-252-05	`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	43975-252-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43975-252-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A203490-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13
A203490-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13
A203490-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13
A203490-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13
A203490-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13
A203490-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203490-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203490-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203490-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203490-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203490-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203490-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203490-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203490-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203490-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203490-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203490-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2016-07-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203490-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2016-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203490-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203490-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203490-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2016-07-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203490-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2016-07-13	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203490-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203490-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203490-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203490-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203490-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203490-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203490-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203490-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203490-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203490-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203490-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203490-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203490-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203490-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203490-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203490-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203490-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203490-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203490-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203490-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203490-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203490-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203490-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203490-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203490-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203490-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203490-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203490-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203490-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203490-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203490-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203490-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203490-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203490-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203490-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203490-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203490-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203490-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203490-005	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203490-006	AB	1	`87673890dc5c…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43975-252-05	EA - Each	43975-252	aec3d1f3-9d2d-4fcb-bc66-4cc033f227ee	1	2016-09-02
43975-252-14	EA - Each	43975-252	f2ba1fc9-d581-4216-989a-782adccbc530	1	2016-09-02

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YF1K15M17Y	TEMOZOLOMIDE	85622-93-1	TEMOZOLOMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43975-252-05	43975025205	5 CAPSULE in 1 BOTTLE, GLASS (43975-252-05)	5 capsule	2016-07-13	0000-00-00	No	No	Current
43975-252-14	43975025214	14 CAPSULE in 1 BOTTLE, GLASS (43975-252-14)	14 capsule	2016-07-13	0000-00-00	No	No	Current