EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE- emtricitabine and tenofovir disoproxil fumarate tablet, film coated 
Zydus Lifesciences Limited

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Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

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

MFG label

NDC 70771-1621-3

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

Rx Only

30 tablets

MFG label

NDC 70771-1622-3

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

Rx Only

30 tablets

MFG label

NDC 70771-1709-3

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

Rx Only

30 tablets

label
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1620
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE100 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE150 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeOVALSize14mm
FlavorImprint Code 1364
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1620-330 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
2NDC:70771-1620-990 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
3NDC:70771-1620-410 in 1 CARTON07/01/2021
3NDC:70771-1620-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21268907/01/2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1621
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE133 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE200 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeRECTANGLESize16mm
FlavorImprint Code 1365
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1621-330 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
2NDC:70771-1621-410 in 1 CARTON07/01/2021
2NDC:70771-1621-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:70771-1621-990 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21268907/01/2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1622
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE167 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE250 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (WHITE TO OFF-WHITE) Scoreno score
ShapeCAPSULE (modified capsule) Size18mm
FlavorImprint Code 1366
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1622-330 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
2NDC:70771-1622-990 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2021
3NDC:70771-1622-410 in 1 CARTON07/01/2021
3NDC:70771-1622-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21268907/01/2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE 
emtricitabine and tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:70771-1709
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S) EMTRICITABINE200 mg
TENOFOVIR DISOPROXIL FUMARATE (UNII: OTT9J7900I) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5) TENOFOVIR DISOPROXIL FUMARATE300 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (off-white) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code 1367
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70771-1709-330 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2021
2NDC:70771-1709-990 in 1 BOTTLE; Type 0: Not a Combination Product03/24/2021
3NDC:70771-1709-410 in 1 CARTON03/24/2021
3NDC:70771-1709-210 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21268903/24/2021
Labeler - Zydus Lifesciences Limited (918596198)
Registrant - Zydus Lifesciences Limited (863362789)
Establishment
NameAddressID/FEIBusiness Operations
Zydus Lifesciences Limited863362789ANALYSIS(70771-1620, 70771-1621, 70771-1622, 70771-1709) , MANUFACTURE(70771-1620, 70771-1621, 70771-1622, 70771-1709)

Revised: 11/2024
Document Id: 8fb1b15c-e324-4410-9a1b-2b3a2ffee3f6
Set id: a0ee89b6-72c3-4b99-8d1c-d7473f1d5ef3
Version: 6
Effective Time: 20241128
 
Zydus Lifesciences Limited