FDA.reportPublic FDA data

Temozolomide

Product NDC
47335-890
11-digit product format
473350890
Labeler code
47335
Product ID
47335-890_7c774570-443b-40da-8038-7cb550f92048
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temozolomide
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA201742
Marketing category
ANDA
Marketing start
2014-02-13
Substance
TEMOZOLOMIDE
Active strength
5 mg/1
Pharmacologic classes
Alkylating Activity [MoA], Alkylating Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
47335-890-21Temozolomide1 in 1 CARTONCAPSULE124
47335-890-21Temozolomide14 in 1 BOTTLECAPSULE1424
47335-890-72Temozolomide1 in 1 BLISTER PACKCAPSULE124
47335-890-72Temozolomide15 in 1 CARTONCAPSULE1524
47335-890-74Temozolomide5 in 1 CARTONCAPSULE524
47335-890-74Temozolomide1 in 1 BLISTER PACKCAPSULE124
47335-890-75Temozolomide1 in 1 BLISTER PACKCAPSULE124
47335-890-75Temozolomide20 in 1 CARTONCAPSULE2024
47335-890-80Temozolomide1 in 1 CARTONCAPSULE124
47335-890-80Temozolomide5 in 1 BOTTLECAPSULE524
47335-890-87Temozolomide1 in 1 CARTONCAPSULE124
47335-890-87Temozolomide20 in 1 BOTTLECAPSULE2024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47335-890-72EA - Each47335-8906032b70b-551e-4f32-8e64-fe279233355912018-08-13
47335-890-74EA - Each47335-890639db929-b584-4ee8-85e1-35595a2d794e12018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMOZOLOMIDEACTIVE INGREDIENTYF1K15M17YTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
TEMOZOLOMIDEACTIVE MOIETYYF1K15M17YTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
AMMONIAINACTIVE INGREDIENT5138Q19F1XTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
GELATININACTIVE INGREDIENT2G86QN327LTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
SHELLACINACTIVE INGREDIENT46N107B71OTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMOZOLOMIDE CAPSULE [SUN PHARMA GLOBAL FZE]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-890TEMOZOLOMIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]23Current NDC, Legacy NDC, 12 package rows20231013_c1e05c21-a411-4493-80de-ede373632475.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
317160temozolomide 100 MG Oral CapsulePSNc1e05c21-a411-4493-80de-ede37363247524
700883temozolomide 140 MG Oral CapsulePSNc1e05c21-a411-4493-80de-ede37363247524
700885temozolomide 180 MG Oral CapsulePSNc1e05c21-a411-4493-80de-ede37363247524
313209temozolomide 20 MG Oral CapsulePSNc1e05c21-a411-4493-80de-ede37363247524
313210temozolomide 250 MG Oral CapsulePSNc1e05c21-a411-4493-80de-ede37363247524
313211temozolomide 5 MG Oral CapsulePSNc1e05c21-a411-4493-80de-ede37363247524
317160temozolomide 100 MG Oral CapsuleSCDc1e05c21-a411-4493-80de-ede37363247524
700883temozolomide 140 MG Oral CapsuleSCDc1e05c21-a411-4493-80de-ede37363247524
700885temozolomide 180 MG Oral CapsuleSCDc1e05c21-a411-4493-80de-ede37363247524
313209temozolomide 20 MG Oral CapsuleSCDc1e05c21-a411-4493-80de-ede37363247524
313210temozolomide 250 MG Oral CapsuleSCDc1e05c21-a411-4493-80de-ede37363247524
313211temozolomide 5 MG Oral CapsuleSCDc1e05c21-a411-4493-80de-ede37363247524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47335-890-21473350890211 BOTTLE in 1 CARTON (47335-890-21) / 14 CAPSULE in 1 BOTTLE1 bottle2014-02-130000-00-00NoNoCurrent
47335-890-724733508907215 BLISTER PACK in 1 CARTON (47335-890-72) / 1 CAPSULE in 1 BLISTER PACK15 blister pack2014-02-130000-00-00NoNoCurrent
47335-890-74473350890745 BLISTER PACK in 1 CARTON (47335-890-74) / 1 CAPSULE in 1 BLISTER PACK5 blister pack2014-02-130000-00-00NoNoCurrent
47335-890-754733508907520 BLISTER PACK in 1 CARTON (47335-890-75) / 1 CAPSULE in 1 BLISTER PACK20 blister pack2014-02-130000-00-00NoNoCurrent
47335-890-80473350890801 BOTTLE in 1 CARTON (47335-890-80) / 5 CAPSULE in 1 BOTTLE1 bottle2014-02-130000-00-00NoNoCurrent
47335-890-87473350890871 BOTTLE in 1 CARTON (47335-890-87) / 20 CAPSULE in 1 BOTTLE1 bottle2014-02-130000-00-00NoNoCurrent