Temozolomide

Product NDC: 70301-2005
11-digit product format: 703012005
Labeler code: 70301
Product ID: 70301-2005_5ca5ff09-bc92-d3ad-e063-6294a90a0fc8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TEMOZOLOMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: OPKO Pharmaceuticals, LLC
Application: ANDA203898
Marketing category: ANDA
Marketing start: 2026-09-16
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
A203898-001	TEMOZOLOMIDE	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10
A203898-002	TEMOZOLOMIDE	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10
A203898-003	TEMOZOLOMIDE	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-02-10
A203898-004	TEMOZOLOMIDE	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-02-10
A203898-005	TEMOZOLOMIDE	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-02-10
A203898-006	TEMOZOLOMIDE	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-02-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203898-003	AB
A203898-004	AB
A203898-005	AB
A203898-006	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	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-02-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-02-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-02-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-02-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-02-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-02-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-02-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-02-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2016-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2016-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2016-02-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2016-02-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL		2016-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL		2016-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203898-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL		2016-02-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203898-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL		2016-02-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203898-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL		2016-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203898-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL		2016-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203898-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL		2016-02-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203898-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL		2016-02-10	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203898-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203898-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203898-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203898-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203898-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203898-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203898-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203898-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203898-006	AB	1	`6a471c1ec25d…`
2019-09-15 20:21 UTC	2019-09	A203898-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203898-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203898-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203898-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203898-005	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203898-006	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203898-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203898-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203898-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203898-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203898-005	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203898-006	AB	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203898-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203898-004	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203898-005	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203898-006	AB	1	`a50c72e98297…`

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70301-2005-1	Temozolomide	1 in 1 PACKET	CAPSULE	1	2
70301-2005-1	Temozolomide	5 in 1 CARTON	CAPSULE	5	2
70301-2005-2	Temozolomide	1 in 1 PACKET	CAPSULE	1	2
70301-2005-2	Temozolomide	14 in 1 CARTON	CAPSULE	14	2

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	9dff10ec-6a55-47b6-a458-b7c39e32dc55	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203898 application number: ANDA203898 ndc (product): 70301-2005
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	f6d762ea-fff0-43e8-b67d-bef19e883dd8	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203898 application number: ANDA203898
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	f743f7e0-74cf-47e5-bf21-f2b75d2596dc	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203898 application number: ANDA203898
Temozolomide	TEMOZOLOMIDE	OPKO Pharmaceuticals, LLC	b3f69c67-db30-4266-8075-9b18c71c9fc1	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203898 application number: ANDA203898

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	9dff10ec-6a55-47b6-a458-b7c39e32dc55	2
317160	temozolomide 100 MG Oral Capsule	SCD	9dff10ec-6a55-47b6-a458-b7c39e32dc55	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70301-2005-1	70301200501	5 PACKET in 1 CARTON (70301-2005-1) / 1 CAPSULE in 1 PACKET	5 packet	2026-09-16	No	No	Current
70301-2005-2	70301200502	14 PACKET in 1 CARTON (70301-2005-2) / 1 CAPSULE in 1 PACKET	14 packet	2026-09-16	No	No	Current