Emtricitabine and Tenofovir Disoproxil Fumarate (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70710-1364-3

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

Rx Only

30 tablets

ZYDUS

image
(click image for full-size original)

NDC 70710-1365-3

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

Rx Only

30 tablets

ZYDUS

image
(click image for full-size original)

NDC 70710-1366-3

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

Rx Only

30 tablets

ZYDUS

image
(click image for full-size original)

NDC 70710-1367-3

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

Rx Only

30 tablets

ZYDUS

image
(click image for full-size original)
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70710-1364
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 100 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 150 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GLYCERYL MONOCAPRYLOCAPRATE
HYPROMELLOSE 2910 (5 MPA.S)
KAOLIN
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
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 Multilevel Packaging
1 NDC:70710-1364-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70710-1364-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70710-1364-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70710-1364-2)
3 NDC:70710-1364-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70710-1364-4)
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:70710-1365
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 133 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 200 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GLYCERYL MONOCAPRYLOCAPRATE
HYPROMELLOSE 2910 (5 MPA.S)
KAOLIN
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
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 Multilevel Packaging
1 NDC:70710-1365-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70710-1365-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70710-1365-2)
2 NDC:70710-1365-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70710-1365-4)
3 NDC:70710-1365-9 90 TABLET, FILM COATED in 1 BOTTLE None
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:70710-1366
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 167 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GLYCERYL MONOCAPRYLOCAPRATE
HYPROMELLOSE 2910 (5 MPA.S)
KAOLIN
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
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 Multilevel Packaging
1 NDC:70710-1366-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70710-1366-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70710-1366-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70710-1366-2)
3 NDC:70710-1366-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70710-1366-4)
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:70710-1367
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE (EMTRICITABINE) EMTRICITABINE 200 mg
TENOFOVIR DISOPROXIL FUMARATE (TENOFOVIR ANHYDROUS) TENOFOVIR DISOPROXIL FUMARATE 300 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
GLYCERYL MONOCAPRYLOCAPRATE
HYPROMELLOSE 2910 (5 MPA.S)
KAOLIN
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
STARCH, CORN
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
TITANIUM DIOXIDE
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color WHITE (WHITE TO OFF-WHITE) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 1367
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70710-1367-3 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70710-1367-9 90 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:70710-1367-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70710-1367-2)
3 NDC:70710-1367-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70710-1367-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212689 03/24/2021
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Zydus Pharmaceuticals (USA) Inc. (156861945)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 863362789 ANALYSIS (70710-1364), ANALYSIS (70710-1365), ANALYSIS (70710-1366), ANALYSIS (70710-1367), MANUFACTURE (70710-1364), MANUFACTURE (70710-1365), MANUFACTURE (70710-1366), MANUFACTURE (70710-1367)

Revised: 07/2021 Zydus Pharmaceuticals (USA) Inc.

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