NDC 0085-1366-01 - TEMODAR

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 0085-1366
Requested NDC: 0085-1366-01
Package NDCs from labels: 0085-1366-05, 0085-1366-03, 0085-1366-04, 0085-1366-01
Manufacturer: Merck Sharp & Dohme LLC
Effective date: 2026-02-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
TEMODAR - Merck Sharp & Dohme LLC	Merck Sharp & Dohme LLC	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL
TEMODAR - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-02-09	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0085-1366-03	TEMODAR	5 in 1 CARTON	CAPSULE	5	40
0085-1366-04	TEMODAR	14 in 1 CARTON	CAPSULE	14	40
0085-1366-05	TEMODAR	1 in 1 PACKET	CAPSULE	1	40

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0085-1366	TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]	38	Current NDC, Legacy NDC, 3 package rows	20241109_046a9011-3911-4d3f-a15f-fbb56d5aad56.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0085-1366-01	EA - Each	0085-1366	f9b9be2c-d013-4ace-8c5c-447c3760161e	1	2012-07-24
0085-1366-02	EA - Each	0085-1366	d72983e4-6350-4fb3-adf4-b441706c71bb	1	2012-07-24
0085-1366-03	EA - Each	0085-1366	6a11137a-886a-432c-921e-bcd14cf3a88d	1	2013-02-13
0085-1366-04	EA - Each	0085-1366	72e1b803-629d-4589-83c8-bd9777da0b50	1	2013-02-13
0085-1366-05	EA - Each	0085-1366	7d7875f3-b770-4b81-b48f-b9d22e6b5356	1	2014-11-05

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

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 3 of 323 · 6,459 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcohol	ISOPROPYL ALCOHOL	Foodhold U.S.A. LLC	a94c023c-5313-4940-90a7-b3061a8b90e1	2026-09-04	Warnings	Exact identifier unii: ND2M416302
Meijer	ISOPROPYL ALCOHOL	Meijer Distribution Inc	ca008d84-cf51-3703-e053-2a95a90a9bf1	2026-09-04	Warnings	Exact identifier unii: ND2M416302
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
Walmart	ISOPROPYL ALCOHOL	Walmart, Inc.	2eff98ba-5736-b07e-e063-6394a90aeea9	2026-09-04	Warnings	Exact identifier unii: ND2M416302
Walgreen Alcohol	ISOPROPYL ALCOHOL	Walgreens Company	deeae1ea-3d81-4260-95be-c4f328e3fdef	2026-09-04	Warnings	Exact identifier unii: ND2M416302
Equate	ETHYL ALCOHOL	Wal-Mart Stores Inc.	ed3796ee-3078-e850-e053-2a95a90a318a	2026-09-03	Warnings	Exact identifier unii: 3K9958V90M
Equate	ETHYL ALCOHOL	Wal-Mart Stores Inc.	ed63bd55-941f-9785-e053-2995a90a5952	2026-09-03	Warnings	Exact identifier unii: 3K9958V90M
Dollar General	ISOPROPYL ALCOHOL	Dollar General Corporation	00b2ef34-42d9-523c-e063-6294a90a753d	2026-09-03	Warnings	Exact identifier unii: ND2M416302
Signature Select Alcohol Prep Pads	ISOPROPYL ALCOHOL	Better Living Brands LLC	31ce72e3-03a3-1608-e063-6394a90ad850	2026-09-03	Warnings	Exact identifier unii: ND2M416302
SurviveX Sting Relief	STING RELIEF WIPE	Changzhou Maokang Medical Products Co., Ltd.	5a83b1f1-c8dc-cf07-e063-6394a90a20ca	2026-09-03	Warnings	Exact identifier unii: ND2M416302
SurviveX Antiseptic Wipes	BZK ANTISEPTIC CLEANING WIPE	Changzhou Maokang Medical Products Co., Ltd.	5a82d9fb-dff8-1c89-e063-6394a90a32c9	2026-09-03	Warnings	Exact identifier unii: ND2M416302
Alcohol	ISOPROPYL ALCOHOL	Rite Aid Corporation	5104f9ab-0b28-449f-a55a-5438713a24df	2026-09-02	Warnings	Exact identifier unii: ND2M416302
biom Sanitizing Alcohol Wipes - Eucalyptus Chill	ALCOHOL	Biom Innovations Inc	23a89b5b-ee5f-4480-e063-6394a90a03b4	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Wild Watermelon	ALCOHOL	Church & Dwight Co., Inc	5a8186f8-2f47-e57c-e063-6394a90a723a	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M
Alcohol	ISOPROPYL ALCOHOL	The Kroger Company	6551187f-5cde-4149-931f-b057bd760750	2026-09-02	Warnings	Exact identifier unii: ND2M416302
Touchland Power Mist Hand Sanitizer Aloe You	ALCOHOL	Church & Dwight Co., Inc.	5a83e963-6a61-fa59-e063-6394a90ade6c	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Berry Bliss	ALCOHOL	Church & Dwight Co., Inc.	5a83fc8f-31db-fd2a-e063-6294a90a8c43	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Blue Sandalwood	ALCOHOL	Church & Dwight Co., Inc.	5a840981-765b-07f1-e063-6294a90ac6a3	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Citrus Grove	ALCOHOL	Church & Dwight Co., Inc.	5a84344b-4ddb-32e5-e063-6394a90a628b	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hand Sanitizer Frosted Mint	ALCOHOL	Church & Dwight Co., Inc.	5a8445e6-42cc-3e55-e063-6394a90ac0e1	2026-09-02	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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