TEMOZOLOMIDE

Product NDC: 59923-710
11-digit product format: 599230710
Labeler code: 59923
Product ID: 59923-710_c1241f17-210e-2d38-e053-2a95a90a56ae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Areva Pharmaceuticals
Application: ANDA204639
Marketing category: ANDA
Marketing start: 2019-01-25
Marketing end: 0000-00-00
Substance: TEMOZOLOMIDE
Active strength: 140 mg/1
Pharmacologic classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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	59923-710		I	Inactivated by FDA		2026-10-05
excluded package	package	59923-710	59923-710-14	I	Inactivated by FDA		2026-10-05

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	TE codes	Approval date
A204639-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23
A204639-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23
A204639-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23
A204639-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23
A204639-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23
A204639-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A204639-001	AB
A204639-002	AB
A204639-003	AB
A204639-004	AB
A204639-005	AB
A204639-006	AB

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	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204639-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204639-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204639-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204639-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204639-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204639-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204639-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204639-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204639-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204639-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204639-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204639-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-11-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204639-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204639-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204639-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-11-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204639-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-11-23	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 5 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-14 00:12 UTC	2019-12	A204639-005	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204639-006	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204639-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204639-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204639-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204639-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204639-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204639-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204639-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204639-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204639-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204639-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204639-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204639-006	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204639-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204639-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204639-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204639-004	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204639-005	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204639-006	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204639-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204639-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204639-003	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204639-004	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204639-005	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204639-006	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204639-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204639-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204639-003	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204639-004	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204639-005	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204639-006	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204639-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204639-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204639-003	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204639-004	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204639-005	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204639-006	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204639-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204639-002	AB	1	`9b2671bbb829…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
3afbbf09-a1e0-475e-b654-466d26d19d69	Product name	9	20170706

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59923-710-14	2026-01-29	C162847	48780-1	f386c649-f525-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999
59923-710-14	2024-02-02	C162847	48780-1	f386c649-f525-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999
59923-710-14	2023-01-30	C162847	48780-1	f386c649-f525-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES USP safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES USP. TEMOZOLOMIDE capsules USP, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59923-710-14	TEMOZOLOMIDE	1 in 1 CARTON	CAPSULE	1		8
59923-710-14	TEMOZOLOMIDE	14 in 1 BOTTLE, GLASS	CAPSULE	14		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59923-710-14	EA - Each	59923-710	6c796056-c9c6-4fa9-9b8c-a36b5afbf1a8	1	2019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59923-710	TEMOZOLOMIDE CAPSULE [AREVA PHARMACEUTICALS]	8	Legacy NDC, 2 package rows	20240203_7d4fb55d-4837-0ea4-e053-2a91aa0afe70.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
317160	temozolomide 100 MG Oral Capsule	PSN	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
700883	temozolomide 140 MG Oral Capsule	PSN	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
700885	temozolomide 180 MG Oral Capsule	PSN	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
313209	temozolomide 20 MG Oral Capsule	PSN	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
313210	temozolomide 250 MG Oral Capsule	PSN	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
313211	temozolomide 5 MG Oral Capsule	PSN	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
317160	temozolomide 100 MG Oral Capsule	SCD	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
700883	temozolomide 140 MG Oral Capsule	SCD	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
700885	temozolomide 180 MG Oral Capsule	SCD	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
313209	temozolomide 20 MG Oral Capsule	SCD	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
313210	temozolomide 250 MG Oral Capsule	SCD	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8
313211	temozolomide 5 MG Oral Capsule	SCD	7d4fb55d-4837-0ea4-e053-2a91aa0afe70	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
59923-710-14	59923071014	1 BOTTLE, GLASS in 1 CARTON (59923-710-14) > 14 CAPSULE in 1 BOTTLE, GLASS	2019-01-25	0000-00-00	No	No	Current