FDA.reportPublic FDA data

NDC 0085-3004-01 - 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
0085-3004
Requested NDC
0085-3004-01
Package NDCs from labels
0085-3004-05, 0085-3004-03, 0085-3004-04, 0085-3004-01
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
LabelManufacturerEffective dateType
TEMODAR - Merck Sharp & Dohme LLCMerck Sharp & Dohme LLC2026-02-20HUMAN PRESCRIPTION DRUG LABEL
TEMODAR - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-02-09HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0085-3004-03TEMODAR5 in 1 CARTONCAPSULE540
0085-3004-04TEMODAR14 in 1 CARTONCAPSULE1440
0085-3004-05TEMODAR1 in 1 PACKETCAPSULE140

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0085-3004TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]38Current NDC, Legacy NDC, 3 package rows20241109_046a9011-3911-4d3f-a15f-fbb56d5aad56.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-3004-01EA - Each0085-3004518dc0cc-46d2-4a51-bb07-3a8cd00dd0e312012-07-24
0085-3004-02EA - Each0085-3004a09570b8-7ca3-4f9b-9066-0a3e73058c0112012-07-24
0085-3004-03EA - Each0085-3004edb05132-e975-4707-9504-07b5d79be98e12013-02-13
0085-3004-04EA - Each0085-30042e13f29a-d49a-4d8a-9a54-8946ce229dec12013-02-13
0085-3004-05EA - Each0085-3004800c2ad4-1fbc-456e-9f6c-ac845fc8267512013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TemozolomideACTIVE INGREDIENTYF1K15M17YTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
TemozolomideACTIVE MOIETYYF1K15M17YTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
alcoholINACTIVE INGREDIENT3K9958V90MTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
ferric oxide redINACTIVE INGREDIENT1K09F3G675TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
gelatinINACTIVE INGREDIENT2G86QN327LTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
hydrochloric acidINACTIVE INGREDIENTQTT17582CBTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
mannitolINACTIVE INGREDIENT3OWL53L36ATEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
shellacINACTIVE INGREDIENT46N107B71OTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
stearic acidINACTIVE INGREDIENT4ELV7Z65APTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
tartaric acidINACTIVE INGREDIENTW4888I119HTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
threonineINACTIVE INGREDIENT2ZD004190STEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
trisodium citrate dihydrateINACTIVE INGREDIENTB22547B95KTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
waterINACTIVE INGREDIENT059QF0KO0RTEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME CORP.]22
TemozolomideACTIVE INGREDIENTYF1K15M17YTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TemozolomideACTIVE MOIETYYF1K15M17YTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
shellacINACTIVE INGREDIENT46N107B71OTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
stearic acidINACTIVE INGREDIENT4ELV7Z65APTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
tartaric acidINACTIVE INGREDIENTW4888I119HTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMODAR (TEMOZOLOMIDE) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
waterINACTIVE INGREDIENT059QF0KO0RTEMODAR (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 9 of 323 · 6,459 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb83a5eef-e2ae-4044-9dce-fd69a5ec5e812026-08-14WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
unii: 3K9958V90M
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
unii: 3K9958V90M
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM134 DROPSARSENIC ALBUM, HYDRASTIS, MYRISTICA, NITRIC ACID, PAEONIA, RHUS TOX, SILICEABM Private Limited59023500-89be-cc76-e063-6294a90a6e022026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM173 DROPSECHINACEA, EUPHRASIA, NATRUM MUR, RHUS TOX, SILICEA, SULPHUR, URTICA URENBM Private Limited59036ca4-e7bb-bbe7-e063-6394a90a410a2026-08-14WarningsExact identifier
unii: ETJ7Z6XBU4
CVS Health Nausea ReliefSODIUM CITRATE DIHYDRATECVS PHARMACY,INC.a5f9de6f-70d8-4bb0-8a5b-3dd120df29902026-08-14WarningsExact identifier
unii: B22547B95K
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6da508ab-176c-4cca-aa1b-c161d9160cd12026-08-14WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED CHERRY SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedeba7108c-7d96-4393-9444-b3ce2ec7a0602026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited08deb4c2-4ba4-4ec0-b2d2-5cc7f851df4b2026-08-13WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST BERRY SPRINKLE SWIRL SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited424454c9-c1d3-46ec-b186-9159c29f7a4a2026-08-13WarningsExact identifier
unii: 3K9958V90M
Zep Alcohol SanitizerETHANOLZep Inc.b932a59c-a739-5441-e053-2a95a90a4cfa2026-08-13WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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