Temozolomide

Product NDC: 73043-011
11-digit product format: 730430011
Labeler code: 73043
Product ID: 73043-011_d6ae8576-1b18-45d5-b651-cc290d979032
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Devatis, Inc.
Application: ANDA207658
Marketing category: ANDA
Marketing start: 2017-04-28
Substance: TEMOZOLOMIDE
Active strength: 5 mg/1
Pharmacologic classes: Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 246 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
2026-02-19 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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-005	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-006	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	AB	2017-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-001	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-002	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-003	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	AB	2017-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-004	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	AB	2017-04-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207658-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207658-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207658-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Temozolomide
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TEMOZOLOMIDE	5 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313209	Internal RxNorm lookup
313210	Internal RxNorm lookup
313211	Internal RxNorm lookup
317160	Internal RxNorm lookup
700883	Internal RxNorm lookup
700885	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
6b263fe0-5f06-4889-bf14-4aa185470810	Available on FDA.report

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	Strength	SPL version
73043-011-05	Temozolomide	5 in 1 BOTTLE	CAPSULE	5		1
73043-011-14	Temozolomide	14 in 1 BOTTLE	CAPSULE	14		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73043-011-05	EA - Each	73043-011	c09febfd-f7fa-498d-b6d8-89e1bf9d8208	1	2025-05-14
73043-011-14	EA - Each	73043-011	4c1000e7-9f13-40e3-b288-abe4069ea9eb	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73043-011	TEMOZOLOMIDE CAPSULE [DEVATIS, INC.]	1	Current NDC, 2 package rows	20250221_6b263fe0-5f06-4889-bf14-4aa185470810.zip

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	Bryant Ranch Prepack	79766855-2533-43b1-b60e-1e9daecadad5	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207658 application number: ANDA207658
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	CivicaScript LLC	56245d21-4a42-471e-bbdc-80b129336e2f	2026-04-28	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 ndc (product): 73043-011

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	6b263fe0-5f06-4889-bf14-4aa185470810	1
700883	temozolomide 140 MG Oral Capsule	PSN	6b263fe0-5f06-4889-bf14-4aa185470810	1
700885	temozolomide 180 MG Oral Capsule	PSN	6b263fe0-5f06-4889-bf14-4aa185470810	1
313209	temozolomide 20 MG Oral Capsule	PSN	6b263fe0-5f06-4889-bf14-4aa185470810	1
313210	temozolomide 250 MG Oral Capsule	PSN	6b263fe0-5f06-4889-bf14-4aa185470810	1
313211	temozolomide 5 MG Oral Capsule	PSN	6b263fe0-5f06-4889-bf14-4aa185470810	1
317160	temozolomide 100 MG Oral Capsule	SCD	6b263fe0-5f06-4889-bf14-4aa185470810	1
700883	temozolomide 140 MG Oral Capsule	SCD	6b263fe0-5f06-4889-bf14-4aa185470810	1
700885	temozolomide 180 MG Oral Capsule	SCD	6b263fe0-5f06-4889-bf14-4aa185470810	1
313209	temozolomide 20 MG Oral Capsule	SCD	6b263fe0-5f06-4889-bf14-4aa185470810	1
313210	temozolomide 250 MG Oral Capsule	SCD	6b263fe0-5f06-4889-bf14-4aa185470810	1
313211	temozolomide 5 MG Oral Capsule	SCD	6b263fe0-5f06-4889-bf14-4aa185470810	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
73043-011-05	73043001105	5 CAPSULE in 1 BOTTLE (73043-011-05)	5 capsule	2025-04-01	No	No	Current
73043-011-14	73043001114	14 CAPSULE in 1 BOTTLE (73043-011-14)	14 capsule	2025-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Temozolomide	Bryant Ranch Prepack	2026-06-09	HUMAN PRESCRIPTION DRUG LABEL	101
Temozolomide	Devatis, Inc. \| Deva Holding A.S	2024-11-30	Human Prescription Drug Label	1