TEMOZOLOMIDE- temozolomide capsule
Zydus Lifesciences Limited

----------

TEMOZOLOMIDE CAPSULES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1092-6 in bottle of 5 capsules

Temozolomide Capsules, 5 mg

Rx only

5 capsules

NDC 70771-1093-6 in bottle of 5 capsules

Temozolomide Capsules, 20 mg

Rx only

5 capsules

NDC 70771-1094-6 in bottle of 5 capsules

Temozolomide Capsules, 100 mg

Rx only

5 capsules

NDC 70771-1095-6 in bottle of 5 capsules

Temozolomide Capsules, 140 mg

Rx only

5 capsules

NDC 70771-1096-6 in bottle of 5 capsules

Temozolomide Capsules, 180 mg

Rx only

5 capsules

NDC 70771-1097-6 in bottle of 5 capsules

Temozolomide Capsules, 250 mg

Rx only

5 capsules

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1092
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)	TEMOZOLOMIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	GREEN (GREEN) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	11mm
Flavor		Imprint Code	751
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1092-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025
2	NDC:70771-1092-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206750	10/26/2017	05/14/2025

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1093
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)	TEMOZOLOMIDE	20 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	YELLOW (YELLOW) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	11mm
Flavor		Imprint Code	752
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1093-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025
2	NDC:70771-1093-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206750	10/26/2017	05/14/2025

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1094
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)	TEMOZOLOMIDE	100 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	PINK (PINK) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	16mm
Flavor		Imprint Code	753
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1094-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025
2	NDC:70771-1094-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206750	10/26/2017	05/14/2025

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1095
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)	TEMOZOLOMIDE	140 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	BLUE (BLUE) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	18mm
Flavor		Imprint Code	754
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1095-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025
2	NDC:70771-1095-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206750	10/26/2017	05/14/2025

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1096
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)	TEMOZOLOMIDE	180 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	ORANGE (ORANGE) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	21mm
Flavor		Imprint Code	755
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1096-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025
2	NDC:70771-1096-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206750	10/26/2017	05/14/2025

TEMOZOLOMIDE
temozolomide capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1097
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TEMOZOLOMIDE (UNII: YF1K15M17Y) (TEMOZOLOMIDE - UNII:YF1K15M17Y)	TEMOZOLOMIDE	250 mg

Ingredient Name	Strength
Inactive Ingredients
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
Color	WHITE (WHITE) , WHITE (WHITE)	Score	no score
Shape	CAPSULE (CAPSULE)	Size	24mm
Flavor		Imprint Code	756
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1097-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025
2	NDC:70771-1097-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017	03/25/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206750	10/26/2017	05/14/2025

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (918596198)

Name	Address	ID/FEI	Business Operations
Establishment
Zydus Lifesciences Limited		863362789	ANALYSIS(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: 12/2024

Document Id: a86159d9-ba4a-4641-bdb4-096a312e8ef2

Set id: 6dad88d9-e73f-4d12-8e28-7abca243d049

Version: 6

Effective Time: 20241204

Zydus Lifesciences Limited