DailyMed - EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

NDC Code(s): 70771-1620-2, 70771-1620-3, 70771-1620-4, 70771-1620-9, view more
70771-1621-2, 70771-1621-3, 70771-1621-4, 70771-1621-9, 70771-1622-2, 70771-1622-3, 70771-1622-4, 70771-1622-9, 70771-1709-2, 70771-1709-3, 70771-1709-4, 70771-1709-9
Packager: Zydus Lifesciences Limited

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

Drug Label Information

Updated September 26, 2023

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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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

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

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA212689	03/24/2021

Labeler - Zydus Lifesciences Limited (918596198)

Registrant - Zydus Lifesciences Limited (863362789)

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

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Published Date (What is this?)	Version	Files
Sep 27, 2023	5 (current)	download
Oct 4, 2022	4	download
Nov 23, 2021	3	download
Mar 24, 2021	2	download

	RxCUI	RxNorm NAME	RxTTY
1	476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	PSN
2	476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet	SCD
3	476556	emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (tenofovir disoproxil 245 MG) Oral Tablet	SY
4	1744001	emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet	PSN
5	1744001	emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet	SCD
6	1744001	emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (tenofovir disoproxil 122.5 MG) Oral Tablet	SY
7	1744005	emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet	PSN
8	1744005	emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet	SCD
9	1744005	emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (tenofovir disoproxil 163 MG) Oral Tablet	SY
10	1744009	emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet	PSN
11	1744009	emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet	SCD
12	1744009	emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (tenofovir disoproxil 204 MG) Oral Tablet	SY

Label: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

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	NDC
1	70771-1620-2
2	70771-1620-3
3	70771-1620-4
4	70771-1620-9
5	70771-1621-2
6	70771-1621-3
7	70771-1621-4
8	70771-1621-9
9	70771-1622-2
10	70771-1622-3
11	70771-1622-4
12	70771-1622-9
13	70771-1709-2
14	70771-1709-3
15	70771-1709-4
16	70771-1709-9

Label: EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

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Drug Label Info

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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

Number of versions: 4

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

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EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

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