EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Emtricitabine and tenofovir disoproxil fumarate by

Drug Labeling and Warnings

Emtricitabine and tenofovir disoproxil fumarate by is a Prescription medication manufactured, distributed, or labeled by Cadila Healthcare Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

SPL MEDGUIDE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 70771-1620-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 100 mg/150 mg

Rx Only

30 tablets

NDC: 70771-1621-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 133 mg/200 mg

Rx Only

30 tablets

NDC: 70771-1622-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 167 mg/250 mg

Rx Only

30 tablets

NDC: 70771-1709-3

Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg

Rx Only

30 tablets

INGREDIENTS AND APPEARANCE

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1620
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S)	EMTRICITABINE	100 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	TENOFOVIR DISOPROXIL FUMARATE	150 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
KAOLIN (UNII: 24H4NWX5CO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	OVAL	Size	14mm
Flavor		Imprint Code	1364
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1620-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
2	NDC: 70771-1620-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
3	NDC: 70771-1620-4	10 in 1 CARTON	07/01/2021
3	NDC: 70771-1620-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212689	07/01/2021

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1621
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S)	EMTRICITABINE	133 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	TENOFOVIR DISOPROXIL FUMARATE	200 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
KAOLIN (UNII: 24H4NWX5CO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	RECTANGLE	Size	16mm
Flavor		Imprint Code	1365
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1621-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
2	NDC: 70771-1621-4	10 in 1 CARTON	07/01/2021
2	NDC: 70771-1621-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 70771-1621-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212689	07/01/2021

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1622
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S)	EMTRICITABINE	167 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	TENOFOVIR DISOPROXIL FUMARATE	250 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
KAOLIN (UNII: 24H4NWX5CO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	WHITE (WHITE TO OFF-WHITE)	Score	no score
Shape	CAPSULE (modified capsule)	Size	18mm
Flavor		Imprint Code	1366
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1622-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
2	NDC: 70771-1622-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2021
3	NDC: 70771-1622-4	10 in 1 CARTON	07/01/2021
3	NDC: 70771-1622-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212689	07/01/2021

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70771-1709
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S)	EMTRICITABINE	200 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)	TENOFOVIR DISOPROXIL FUMARATE	300 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
GLYCERYL MONOCAPRYLOCAPRATE (UNII: G7515SW10N)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
KAOLIN (UNII: 24H4NWX5CO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	WHITE (off-white)	Score	no score
Shape	CAPSULE	Size	19mm
Flavor		Imprint Code	1367
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70771-1709-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2021
2	NDC: 70771-1709-9	90 in 1 BOTTLE; Type 0: Not a Combination Product	03/24/2021
3	NDC: 70771-1709-4	10 in 1 CARTON	03/24/2021
3	NDC: 70771-1709-2	10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA212689	03/24/2021

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (863362789)

Establishment
Name	Address	ID/FEI	Business Operations
Zydus Lifesciences Limited		863362789	ANALYSIS(70771-1620, 70771-1621, 70771-1622, 70771-1709) , MANUFACTURE(70771-1620, 70771-1621, 70771-1622, 70771-1709)