FDA.reportPublic FDA data

Temozolomide

Product NDC
65162-803
11-digit product format
651620803
Labeler code
65162
Product ID
65162-803_7cf62d84-45c0-405c-975b-3dbcbcf5ee27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA203691
Marketing category
ANDA
Marketing start
2015-04-03
Substance
TEMOZOLOMIDE
Active strength
100 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMOZOLOMIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYF1K15M17Y
Rxcui313209, 313210, 313211, 317160, 700883, 700885

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3afbbf09-a1e0-475e-b654-466d26d19d69Product name920170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-803-14Temozolomide1 in 1 CARTONCAPSULE126
65162-803-14Temozolomide14 in 1 BOTTLECAPSULE1426
65162-803-51Temozolomide1 in 1 CARTONCAPSULE126
65162-803-51Temozolomide5 in 1 BOTTLECAPSULE526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-803-14EA - Each65162-803a479f190-c94e-42b7-9ccc-bb9a7a5152ac12015-06-09
65162-803-51EA - Each65162-803c1d91019-54b3-4e6c-9195-f4f8aa91ddc412015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMOZOLOMIDEACTIVE INGREDIENTYF1K15M17YTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TEMOZOLOMIDEACTIVE MOIETYYF1K15M17YTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
GELATININACTIVE INGREDIENT2G86QN327LTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SHELLACINACTIVE INGREDIENT46N107B71OTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-803TEMOZOLOMIDE CAPSULE [AMNEAL PHARMACEUTICALS LLC]26Current NDC, Legacy NDC, 4 package rows20250124_6c8529ec-8936-4fec-a1a5-2b285c7e4859.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSN6c8529ec-8936-4fec-a1a5-2b285c7e485926
700883temozolomide 140 MG Oral CapsulePSN6c8529ec-8936-4fec-a1a5-2b285c7e485926
700885temozolomide 180 MG Oral CapsulePSN6c8529ec-8936-4fec-a1a5-2b285c7e485926
313209temozolomide 20 MG Oral CapsulePSN6c8529ec-8936-4fec-a1a5-2b285c7e485926
313210temozolomide 250 MG Oral CapsulePSN6c8529ec-8936-4fec-a1a5-2b285c7e485926
313211temozolomide 5 MG Oral CapsulePSN6c8529ec-8936-4fec-a1a5-2b285c7e485926
317160temozolomide 100 MG Oral CapsuleSCD6c8529ec-8936-4fec-a1a5-2b285c7e485926
700883temozolomide 140 MG Oral CapsuleSCD6c8529ec-8936-4fec-a1a5-2b285c7e485926
700885temozolomide 180 MG Oral CapsuleSCD6c8529ec-8936-4fec-a1a5-2b285c7e485926
313209temozolomide 20 MG Oral CapsuleSCD6c8529ec-8936-4fec-a1a5-2b285c7e485926
313210temozolomide 250 MG Oral CapsuleSCD6c8529ec-8936-4fec-a1a5-2b285c7e485926
313211temozolomide 5 MG Oral CapsuleSCD6c8529ec-8936-4fec-a1a5-2b285c7e485926

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-803-14651620803141 BOTTLE in 1 CARTON (65162-803-14) / 14 CAPSULE in 1 BOTTLE1 bottle2015-04-030000-00-00NoNoCurrent
65162-803-51651620803511 BOTTLE in 1 CARTON (65162-803-51) / 5 CAPSULE in 1 BOTTLE1 bottle2015-04-030000-00-00NoNoCurrent