NDC Code(s) : 69238-2092-3, 69238-2093-3, 69238-2094-3, 69238-2095-3
Packager : Amneal Pharmaceuticals NY LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-2092
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE100 mg
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR DISOPROXIL FUMARATE150 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white (white to off-white) Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code AC51
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-2092-330 in 1 BOTTLE Type 0: Not a Combination Product26/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209721 08/26/2018
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-2093
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE133 mg
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR DISOPROXIL FUMARATE200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (Modified capsule) Size 16 mm
Flavor Imprint Code AC52
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-2093-330 in 1 BOTTLE Type 0: Not a Combination Product26/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209721 08/26/2018
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-2094
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE167 mg
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR DISOPROXIL FUMARATE250 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE (Modified capsule) Size 18 mm
Flavor Imprint Code AC53
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-2094-330 in 1 BOTTLE Type 0: Not a Combination Product26/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209721 08/26/2018
Emtricitabine and Tenofovir Disoproxil FumarateEmtricitabine and Tenofovir Disoproxil Fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-2095
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EMTRICITABINE(UNII: G70B4ETF4S)
(EMTRICITABINE - UNII:G70B4ETF4S) 		EMTRICITABINE200 mg
TENOFOVIR DISOPROXIL FUMARATE(UNII: OTT9J7900I)
(TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) 		TENOFOVIR DISOPROXIL FUMARATE300 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM STEARATE(UNII: 776XM7047L)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color white (white to off-white) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code AC24
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69238-2095-330 in 1 BOTTLE Type 0: Not a Combination Product26/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209721 08/26/2018

LABELER - Amneal Pharmaceuticals NY LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals Private Limited 650762060 analysis(69238-2092, 69238-2093, 69238-2094, 69238-2095), label(69238-2092, 69238-2093, 69238-2094, 69238-2095), manufacture(69238-2092, 69238-2093, 69238-2094, 69238-2095), pack(69238-2092, 69238-2093, 69238-2094, 69238-2095)

PRINCIPAL DISPLAY PANEL

NDC 69238-2092-3

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

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

hg

NDC 69238-2093-3

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

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

hg

NDC 69238-2094-3

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

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

hg

NDC 69238-2095-3

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

Rx only

30 Tablets

Amneal Pharmaceuticals LLC

hg