DailyMed - TEMOZOLOMIDE capsule

NDC Code(s): 70771-1092-6, 70771-1092-7, 70771-1093-6, 70771-1093-7, view more
70771-1094-6, 70771-1094-7, 70771-1095-6, 70771-1095-7, 70771-1096-6, 70771-1096-7, 70771-1097-6, 70771-1097-7
Packager: Zydus Lifesciences Limited

Category: HUMAN PRESCRIPTION DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 17, 2022

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

SPL UNCLASSIFIED SECTION
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

INGREDIENTS AND APPEARANCE

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
Packaging
1	NDC:70771-1092-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017
2	NDC:70771-1092-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017

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

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
Packaging
1	NDC:70771-1093-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017
2	NDC:70771-1093-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017

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

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
Packaging
1	NDC:70771-1094-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017
2	NDC:70771-1094-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017

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

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
Packaging
1	NDC:70771-1095-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017
2	NDC:70771-1095-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017

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

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
Packaging
1	NDC:70771-1096-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017
2	NDC:70771-1096-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017

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

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
Packaging
1	NDC:70771-1097-6	5 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017
2	NDC:70771-1097-7	14 in 1 BOTTLE; Type 0: Not a Combination Product	10/26/2017

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

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)

View All Sections

Published Date (What is this?)	Version	Files
Oct 27, 2022	5 (current)	download
Sep 24, 2020	4	download
Dec 17, 2019	3	download
Dec 1, 2017	2	download
Oct 26, 2017	1	download

	RxCUI	RxNorm NAME	RxTTY
1	313209	temozolomide 20 MG Oral Capsule	PSN
2	313209	temozolomide 20 MG Oral Capsule	SCD
3	313210	temozolomide 250 MG Oral Capsule	PSN
4	313210	temozolomide 250 MG Oral Capsule	SCD
5	313211	temozolomide 5 MG Oral Capsule	PSN
6	313211	temozolomide 5 MG Oral Capsule	SCD
7	317160	temozolomide 100 MG Oral Capsule	PSN
8	317160	temozolomide 100 MG Oral Capsule	SCD
9	700883	temozolomide 140 MG Oral Capsule	PSN
10	700883	temozolomide 140 MG Oral Capsule	SCD
11	700885	temozolomide 180 MG Oral Capsule	PSN
12	700885	temozolomide 180 MG Oral Capsule	SCD

Label: TEMOZOLOMIDE capsule

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

	NDC
1	70771-1092-6
2	70771-1092-7
3	70771-1093-6
4	70771-1093-7
5	70771-1094-6
6	70771-1094-7
7	70771-1095-6
8	70771-1095-7
9	70771-1096-6
10	70771-1096-7
11	70771-1097-6
12	70771-1097-7

Label: TEMOZOLOMIDE capsule

View Package Photos

VIEW MORE

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Find additional resources

Safety

Related Resources

More Info on this Drug

TEMOZOLOMIDE capsule

Number of versions: 5

TEMOZOLOMIDE capsule

TEMOZOLOMIDE capsule

To receive this label RSS feed

To receive all DailyMed Updates for the last seven days

What will I get with the DailyMed RSS feed?

How to discontinue the RSS feed

Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?

TEMOZOLOMIDE capsule

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.