TEMODAR

Product NDC: 0085-1417
11-digit product format: 000851417
Labeler code: 0085
Product ID: 0085-1417_40ceddc0-83a2-4b3b-8953-fd0078a41133
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Temozolomide
Dosage form: CAPSULE
Route: ORAL
Labeler: Merck Sharp & Dohme LLC
Application: NDA021029
Marketing category: NDA
Marketing start: 1999-08-11
Substance: TEMOZOLOMIDE
Active strength: 250 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 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	RLD / RS	Approval date
N021029-001	TEMODAR	TEMOZOLOMIDE	5MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-002	TEMODAR	TEMOZOLOMIDE	20MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-003	TEMODAR	TEMOZOLOMIDE	100MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-004	TEMODAR	TEMOZOLOMIDE	250MG	CAPSULE / ORAL	RLD	1999-08-11
N021029-005	TEMODAR	TEMOZOLOMIDE	140MG	CAPSULE / ORAL	RLD	2006-10-19
N021029-006	TEMODAR	TEMOZOLOMIDE	180MG	CAPSULE / ORAL	RLD	2006-10-19

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-005	TEMODAR	140MG	CAPSULE / ORAL	RLD	2006-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021029-006	TEMODAR	180MG	CAPSULE / ORAL	RLD	2006-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-001	TEMODAR	5MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-002	TEMODAR	20MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-003	TEMODAR	100MG	CAPSULE / ORAL	RLD	1999-08-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021029-004	TEMODAR	250MG	CAPSULE / ORAL	RLD	1999-08-11	`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	N021029-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-005	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021029-006	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021029-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-005	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021029-006	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021029-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-005	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021029-006	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021029-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-005	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021029-006	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021029-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-005	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021029-006	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021029-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-005	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021029-006	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021029-004	AB	1	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TEMOZOLOMIDE	250 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 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
261288	Internal RxNorm lookup
261289	Internal RxNorm lookup
261290	Internal RxNorm lookup
261291	Internal RxNorm lookup
313209	Internal RxNorm lookup
313210	Internal RxNorm lookup
313211	Internal RxNorm lookup
317160	Internal RxNorm lookup
700883	Internal RxNorm lookup
700885	Internal RxNorm lookup
705617	Internal RxNorm lookup
705619	Internal RxNorm lookup
835945	Internal RxNorm lookup
835948	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
046a9011-3911-4d3f-a15f-fbb56d5aad56	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810
3afbbf09-a1e0-475e-b654-466d26d19d69	Product name	9	20170706
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0085-1417-02	TEMODAR	5 in 1 CARTON	CAPSULE	5		40
0085-1417-03	TEMODAR	1 in 1 PACKET	CAPSULE	1		40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-1417-01	EA - Each	0085-1417	fb52366e-9e67-4a12-b1e5-47a682b23bc1	1	2012-07-24
0085-1417-02	EA - Each	0085-1417	1cf97d71-34f6-4261-b6fe-695e3b9aa15a	1	2013-02-13
0085-1417-03	EA - Each	0085-1417	7426dd24-86d1-478e-aaa2-1781cff7a243	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Temozolomide	ACTIVE INGREDIENT	YF1K15M17Y	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
Temozolomide	ACTIVE MOIETY	YF1K15M17Y	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
hydrochloric acid	INACTIVE INGREDIENT	QTT17582CB	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
mannitol	INACTIVE INGREDIENT	3OWL53L36A	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
shellac	INACTIVE INGREDIENT	46N107B71O	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
tartaric acid	INACTIVE INGREDIENT	W4888I119H	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
threonine	INACTIVE INGREDIENT	2ZD004190S	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
trisodium citrate dihydrate	INACTIVE INGREDIENT	B22547B95K	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
water	INACTIVE INGREDIENT	059QF0KO0R	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]	22
Temozolomide	ACTIVE INGREDIENT	YF1K15M17Y	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
Temozolomide	ACTIVE MOIETY	YF1K15M17Y	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
alcohol	INACTIVE INGREDIENT	3K9958V90M	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
ammonia	INACTIVE INGREDIENT	5138Q19F1X	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
anhydrous lactose	INACTIVE INGREDIENT	3SY5LH9PMK	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
butyl alcohol	INACTIVE INGREDIENT	8PJ61P6TS3	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
FD&C Blue No. 2	INACTIVE INGREDIENT	L06K8R7DQK	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
gelatin	INACTIVE INGREDIENT	2G86QN327L	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
shellac	INACTIVE INGREDIENT	46N107B71O	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
sodium starch glycolate type A potato	INACTIVE INGREDIENT	5856J3G2A2	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
tartaric acid	INACTIVE INGREDIENT	W4888I119H	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0085-1417	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]	38	Current NDC, Legacy NDC, 2 package rows	20241109_046a9011-3911-4d3f-a15f-fbb56d5aad56.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TEMODAR	TEMOZOLOMIDE	Merck Sharp & Dohme LLC	046a9011-3911-4d3f-a15f-fbb56d5aad56	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021029 application number: NDA021029 ndc (product): 0085-1417

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
835948	Temodar 100 MG Injection	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261290	Temodar 100 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
705617	Temodar 140 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
705619	Temodar 180 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261289	Temodar 20 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261291	Temodar 250 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261288	Temodar 5 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
835945	temozolomide 100 MG Injection	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
317160	temozolomide 100 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
700883	temozolomide 140 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
700885	temozolomide 180 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
313209	temozolomide 20 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
313210	temozolomide 250 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
313211	temozolomide 5 MG Oral Capsule	PSN	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
835948	temozolomide 100 MG Injection [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261290	temozolomide 100 MG Oral Capsule [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
705617	temozolomide 140 MG Oral Capsule [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
705619	temozolomide 180 MG Oral Capsule [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261289	temozolomide 20 MG Oral Capsule [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261291	temozolomide 250 MG Oral Capsule [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261288	temozolomide 5 MG Oral Capsule [Temodar]	SBD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
835945	temozolomide 100 MG Injection	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
317160	temozolomide 100 MG Oral Capsule	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
700883	temozolomide 140 MG Oral Capsule	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
700885	temozolomide 180 MG Oral Capsule	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
313209	temozolomide 20 MG Oral Capsule	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
313210	temozolomide 250 MG Oral Capsule	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
313211	temozolomide 5 MG Oral Capsule	SCD	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
835948	Temodar 100 MG Injection	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261290	Temodar 100 MG Oral Capsule	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
705617	Temodar 140 MG Oral Capsule	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
705619	Temodar 180 MG Oral Capsule	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261289	Temodar 20 MG Oral Capsule	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261291	Temodar 250 MG Oral Capsule	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261288	Temodar 5 MG Oral Capsule	SY	046a9011-3911-4d3f-a15f-fbb56d5aad56	40
261290	Temodar 100 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
705619	Temodar 180 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261289	Temodar 20 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261291	Temodar 250 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261288	Temodar 5 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
317160	temozolomide 100 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
700885	temozolomide 180 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
313209	temozolomide 20 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
313210	temozolomide 250 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
313211	temozolomide 5 MG Oral Capsule	PSN	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261290	temozolomide 100 MG Oral Capsule [Temodar]	SBD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
705619	temozolomide 180 MG Oral Capsule [Temodar]	SBD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261289	temozolomide 20 MG Oral Capsule [Temodar]	SBD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261291	temozolomide 250 MG Oral Capsule [Temodar]	SBD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261288	temozolomide 5 MG Oral Capsule [Temodar]	SBD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
317160	temozolomide 100 MG Oral Capsule	SCD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
700885	temozolomide 180 MG Oral Capsule	SCD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
313209	temozolomide 20 MG Oral Capsule	SCD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
313210	temozolomide 250 MG Oral Capsule	SCD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
313211	temozolomide 5 MG Oral Capsule	SCD	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261290	Temodar 100 MG Oral Capsule	SY	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
705619	Temodar 180 MG Oral Capsule	SY	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261289	Temodar 20 MG Oral Capsule	SY	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261291	Temodar 250 MG Oral Capsule	SY	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1
261288	Temodar 5 MG Oral Capsule	SY	819571ea-b808-4fd8-93c7-1ea2e33d71cf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0085-1417-02	00085141702	5 PACKET in 1 CARTON (0085-1417-02) / 1 CAPSULE in 1 PACKET (0085-1417-03)	5 packet	1999-08-11	0000-00-00	No	No	Current
0085-1417-03	00085141703	1 in 1 PACKET						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TEMODAR	Merck Sharp & Dohme LLC	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	40
TEMODAR	Physicians Total Care, Inc.	2011-02-09	HUMAN PRESCRIPTION DRUG LABEL	1