FDA.reportPublic FDA data

TEMODAR

Product NDC
0085-1381
11-digit product format
000851381
Labeler code
0085
Product ID
0085-1381_40ceddc0-83a2-4b3b-8953-fd0078a41133
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Merck Sharp & Dohme LLC
Application
NDA022277
Marketing category
NDA
Marketing start
2009-02-27
Substance
TEMOZOLOMIDE
Active strength
2.5 mg/mL
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMOZOLOMIDE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYF1K15M17Y
Rxcui261288, 261289, 261290, 261291, 313209, 313210, 313211, 317160, 700883, 700885, 705617, 705619, 835945, 835948

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3afbbf09-a1e0-475e-b654-466d26d19d69Product name920170706
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0085-1381-01TEMODAR40 mL in 1 VIAL, SINGLE-USEINJECTION, POWDER, LYOPHILIZED,4040
0085-1381-01TEMODAR1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,140

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0085-1381-01EA - Each0085-1381673fbe16-ba48-4837-b5cb-b6b468b3d81112012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0085-1381TEMODAR (TEMOZOLOMIDE) CAPSULE TEMODAR (TEMOZOLOMIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]38Current NDC, Legacy NDC, 2 package rows20241109_046a9011-3911-4d3f-a15f-fbb56d5aad56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
835948Temodar 100 MG InjectionPSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261290Temodar 100 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
705617Temodar 140 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
705619Temodar 180 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261289Temodar 20 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261291Temodar 250 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
261288Temodar 5 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
835945temozolomide 100 MG InjectionPSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
317160temozolomide 100 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
700883temozolomide 140 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
700885temozolomide 180 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
313209temozolomide 20 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
313210temozolomide 250 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
313211temozolomide 5 MG Oral CapsulePSN046a9011-3911-4d3f-a15f-fbb56d5aad5640
835948temozolomide 100 MG Injection [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261290temozolomide 100 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
705617temozolomide 140 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
705619temozolomide 180 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261289temozolomide 20 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261291temozolomide 250 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
261288temozolomide 5 MG Oral Capsule [Temodar]SBD046a9011-3911-4d3f-a15f-fbb56d5aad5640
835945temozolomide 100 MG InjectionSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
317160temozolomide 100 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
700883temozolomide 140 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
700885temozolomide 180 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
313209temozolomide 20 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
313210temozolomide 250 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
313211temozolomide 5 MG Oral CapsuleSCD046a9011-3911-4d3f-a15f-fbb56d5aad5640
835948Temodar 100 MG InjectionSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261290Temodar 100 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
705617Temodar 140 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
705619Temodar 180 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261289Temodar 20 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261291Temodar 250 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640
261288Temodar 5 MG Oral CapsuleSY046a9011-3911-4d3f-a15f-fbb56d5aad5640

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0085-1381-01000851381011 VIAL, SINGLE-USE in 1 CARTON (0085-1381-01) / 40 mL in 1 VIAL, SINGLE-USE2009-02-270000-00-00NoNoCurrent