TENOFOVIR DISOPROXIL FUMARATE tablet, film coated

tenofovir disoproxil fumarate by

Drug Labeling and Warnings

tenofovir disoproxil fumarate by is a Prescription medication manufactured, distributed, or labeled by AIZANT DRUG RESEARCH SOLUTIONS PVT LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

16 HOW SUPPLIED/STORAGE AND HANDLING

Tenofovir disoproxiltablets, 150 mg, are triangle-shaped, white, film-coated tablets containing 150 mg of tenofovirdisoproxilfumarate, which is equivalent to 123 mg of tenofovir disoproxil, are debossed with "100" onone side and "A" on the other side. Each bottle contains 30 tablets, a desiccant (1g silica gel canisteror sachet), and closed with a child-resistant closure. (NDC: 69025-100-01)

Tenofovir disoproxiltablets, 200 mg, are round-shaped, white, film-coated tablets containing 200 mg of tenofovirdisoproxilfumarate, which is equivalent to 163 mg of tenofovir disoproxil, are debossed with "101" onone side and "A" on the other side. Each bottle contains 30 tablets, a desiccant (1g silica gelcanister or sachet), and closed with a child-resistant closure. (NDC: 69025-101-01)

Tenofovir disoproxiltablets, 250 mg, are capsule-shaped, white, film-coated tablets containing 250 mg of tenofovirdisoproxilfumarate, which is equivalent to 204 mg of tenofovir disoproxil, are debossed with "102" onone side and "A" on the other side. Each bottle contains 30 tablets, a desiccant (1g silica gel canisteror sachet), and closed with a child-resistant closure. (NDC: 69025-102-01)

Tenofovir disoproxiltablets, 300 mg, are almond-shaped, light blue, film-coated tablets containing 300 mg oftenofovir disoproxilfumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossedwith "103" on one side and "A" on the other side. Each bottle contains 30tablets, a desiccant (1g silica gel canister or sachet), and closed with a child-resistant closure. (NDC: 69025-103-01)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Tenofovir Disoproxil Fumarate Tablets

NDC: 69025-100-01

150 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets

NDC: 69025-101-01

200 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets

NDC: 69025-102-01

250 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets

NDC: 69025-103-01

300 mg - 30 Tablets

Rx only

INGREDIENTS AND APPEARANCE

TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69025-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5)	tenofovir disoproxil fumarate	150 mg

Product Characteristics
Color	white	Score	no score
Shape	TRIANGLE	Size	10mm
Flavor		Imprint Code	100;A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69025-100-01	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/26/2018

TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69025-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5)	tenofovir disoproxil fumarate	200 mg

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	101;A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69025-101-01	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/26/2018

TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69025-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5)	tenofovir disoproxil fumarate	250 mg

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	102;A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69025-102-01	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/26/2018

TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69025-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5)	tenofovir disoproxil fumarate	300 mg

Product Characteristics
Color	BLUE (light blue)	Score	no score
Shape	FREEFORM (almond-shaped)	Size	17mm
Flavor		Imprint Code	103;A
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69025-103-01	30 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/26/2018

Labeler - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD (650372951)

Registrant - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD (650372951)