TEMOZOLOMIDE - temozolomide capsule 
Zydus Lifesciences Limited

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TEMOZOLOMIDE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1092-6 in bottle of 5 capsules

Temozolomide Capsules, 5 mg

Rx  only

5 capsules

Temozolomide capsules, 5 mg

NDC 70771-1093-6 in bottle of 5 capsules

Temozolomide Capsules, 20 mg

Rx  only

5 capsules

Temozolomide capsules, 20 mg

NDC 70771-1094-6 in bottle of 5 capsules

Temozolomide Capsules, 100 mg

Rx  only

5 capsules

Temozolomide capsules, 100 mg

NDC 70771-1095-6 in bottle of 5 capsules

Temozolomide Capsules, 140 mg

Rx  only

5 capsules

Temozolomide capsules, 140 mg

NDC 70771-1096-6 in bottle of 5 capsules

Temozolomide Capsules, 180 mg

Rx  only

5 capsules

Temozolomide capsules, 180 mg

NDC 70771-1097-6 in bottle of 5 capsules

Temozolomide Capsules, 250 mg

Rx  only

5 capsules

Temozolomide capsules, 250 mg
TEMOZOLOMIDE 
temozolomide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1092
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y) TEMOZOLOMIDE5 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorGREEN (GREEN) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code 751
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1092-65 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
2NDC:70771-1092-714 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675010/26/2017
TEMOZOLOMIDE 
temozolomide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1093
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y) TEMOZOLOMIDE20 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorYELLOW (YELLOW) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size11mm
FlavorImprint Code 752
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1093-65 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
2NDC:70771-1093-714 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675010/26/2017
TEMOZOLOMIDE 
temozolomide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1094
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y) TEMOZOLOMIDE100 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
TARTARIC ACID (UNII: W4888I119H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
ALCOHOL (UNII: 3K9958V90M)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
AMMONIA (UNII: 5138Q19F1X)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
ColorPINK (PINK) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size16mm
FlavorImprint Code 753
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1094-65 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
2NDC:70771-1094-714 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675010/26/2017
TEMOZOLOMIDE 
temozolomide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1095
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y) TEMOZOLOMIDE140 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorBLUE (BLUE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size18mm
FlavorImprint Code 754
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1095-65 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
2NDC:70771-1095-714 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675010/26/2017
TEMOZOLOMIDE 
temozolomide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1096
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y) TEMOZOLOMIDE180 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorORANGE (ORANGE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size21mm
FlavorImprint Code 755
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1096-65 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
2NDC:70771-1096-714 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675010/26/2017
TEMOZOLOMIDE 
temozolomide capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y) TEMOZOLOMIDE250 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
AMMONIA (UNII: 5138Q19F1X)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GELATIN (UNII: 2G86QN327L)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE B POTATO (UNII: 27NA468985)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITE (WHITE) , WHITE (WHITE) Scoreno score
ShapeCAPSULE (CAPSULE) Size24mm
FlavorImprint Code 756
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1097-65 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
2NDC:70771-1097-714 in 1 BOTTLE; Type 0: Not a Combination Product10/26/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20675010/26/2017
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1092, 70771-1093, 70771-1094, 70771-1095, 70771-1096, 70771-1097) , MANUFACTURE(70771-1092, 70771-1093, 70771-1094, 70771-1095, 70771-1096, 70771-1097)

Revised: 10/2022
Document Id: 84b259e3-d098-4384-8e3d-d498ba589408
Set id: 6dad88d9-e73f-4d12-8e28-7abca243d049
Version: 5
Effective Time: 20221017
 
Zydus Lifesciences Limited