Temozolomide

Product NDC: 72162-2661
11-digit product format: 721622661
Labeler code: 72162
Product ID: 72162-2661_44713205-229d-400f-a7f1-e860ab9d3e9d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA207658
Marketing category: ANDA
Marketing start: 2017-04-28
Substance: TEMOZOLOMIDE
Active strength: 100 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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
A207658-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26
A207658-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26
A207658-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26
A207658-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26
A207658-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26
A207658-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207658-001	AB
A207658-002	AB
A207658-003	AB
A207658-004	AB
A207658-005	AB
A207658-006	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	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207658-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207658-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207658-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207658-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207658-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207658-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207658-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207658-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207658-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207658-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Temozolomide
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TEMOZOLOMIDE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
YF1K15M17Y	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
317160	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
79766855-2533-43b1-b60e-1e9daecadad5	Available on FDA.report

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temozolomide	TEMOZOLOMIDE	CivicaScript LLC	56245d21-4a42-471e-bbdc-80b129336e2f	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	79766855-2533-43b1-b60e-1e9daecadad5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658 ndc (product): 72162-2661
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	021b97cc-a76f-44b6-b7be-670d2ae83690	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	c0f2077c-48e6-452e-9f88-e1f2c89df0a2	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	38f17780-8037-44a0-9e84-b7150c9bde12	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	6eb0bd33-582f-43a6-a607-e72b4390c6d3	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Bryant Ranch Prepack	a147b361-262c-49c6-9b8e-7e454f755721	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Ascend Laboratories, LLC	33d67bce-38ae-45fc-a858-d51167b0ecfd	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
Temozolomide	TEMOZOLOMIDE	Devatis, Inc.	6b263fe0-5f06-4889-bf14-4aa185470810	2024-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658

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	Sample	Exclude flag	Status
72162-2661-2	72162266102	5 CAPSULE in 1 BOTTLE (72162-2661-2)	5 capsule	2026-06-09	No	No	Current
72162-2661-4	72162266104	14 CAPSULE in 1 BOTTLE (72162-2661-4)	14 capsule	2026-06-09	No	No	Current