Temozolomide

Product NDC: 23155-776
Requested package NDC: 23155-776-71
11-digit product format: 231550776
Labeler code: 23155
Product ID: 23155-776_e1982c81-2588-45cf-94f7-160a700709e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA078879
Marketing category: ANDA
Marketing start: 2022-06-15
Marketing end: 0000-00-00
Substance: TEMOZOLOMIDE
Active strength: 100 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	23155-776	23155-776-71	D	Discontinued by firm		2026-08-17

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 · 12 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078879-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01
A078879-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01
A078879-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01
A078879-004	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01
A078879-005	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01
A078879-006	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01

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 7 · 252 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078879-005	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078879-006	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078879-005	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078879-006	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078879-005	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078879-006	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078879-005	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078879-006	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078879-005	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078879-006	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078879-005	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	2010-03-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078879-006	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	2010-03-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078879-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	2010-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078879-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	2010-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078879-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	2010-03-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078879-004	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	2010-03-01	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 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	A078879-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078879-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078879-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078879-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078879-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078879-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078879-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078879-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078879-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078879-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078879-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078879-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078879-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078879-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078879-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078879-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078879-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078879-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078879-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078879-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078879-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078879-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078879-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078879-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078879-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078879-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078879-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078879-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078879-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078879-006	AB	1	`bb7c543d1eb4…`
2020-11-12 02:37 UTC	2020-11	A078879-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078879-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078879-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078879-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078879-005	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078879-006	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078879-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078879-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078879-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A078879-004	AB	1	`3f01610625f2…`

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
23155-776-71	23155077671	5 CAPSULE in 1 BOTTLE (23155-776-71)	5 capsule	2022-06-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temozolomide	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. \| Genvion Corporation \| Wavelength Enterprises LTD	2022-04-12	HUMAN PRESCRIPTION DRUG LABEL	1