TENOFOVIR DISOPROXIL FUMARATE- tenofovir disoproxil fumarate tablet, film coated 
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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These highlights do not include all the information needed to use Tenofovir disoproxil Fumarate Tablets safely and effectively. See full prescribing information for tenofovir disoproxil fumarate tablets.

Tenofovir disoproxil fumarate tablets, for oral use
Initial U.S. Approval: 2001

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

Tenofovir Disoproxil Fumarate Tablets

NDC 69025-100-01

150 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets 150 mg Container Label

Tenofovir Disoproxil Fumarate Tablets

NDC 69025-101-01

200 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets, 200 mg Container Label

Tenofovir Disoproxil Fumarate Tablets

NDC 69025-102-01

250 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets, 250 mg Container Label

Tenofovir Disoproxil Fumarate Tablets

NDC 69025-103-01

300 mg - 30 Tablets

Rx only

Tenofovir Disoproxil Fumarate Tablets, 300 mg Container Label
TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69025-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate150 mg
Product Characteristics
ColorwhiteScoreno score
ShapeTRIANGLESize10mm
FlavorImprint Code 100;A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69025-100-0130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/2018
TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69025-101
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate200 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code 101;A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69025-101-0130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/2018
TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69025-102
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate250 mg
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 102;A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69025-102-0130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/2018
TENOFOVIR DISOPROXIL FUMARATE 
tenofovir disoproxil fumarate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69025-103
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
tenofovir disoproxil fumarate (UNII: OTT9J7900I) (tenofovir anhydrous - UNII:W4HFE001U5) tenofovir disoproxil fumarate300 mg
Product Characteristics
ColorBLUE (light blue) Scoreno score
ShapeFREEFORM (almond-shaped) Size17mm
FlavorImprint Code 103;A
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69025-103-0130 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/26/2018
Labeler - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD (650372951)
Registrant - AIZANT DRUG RESEARCH SOLUTIONS PVT LTD (650372951)

Revised: 8/2015
Document Id: e23a06d9-5379-462e-9cb0-9462086c5f3d
Set id: 79b774fe-abcd-47b4-943b-e82fc87bd6df
Version: 1
Effective Time: 20150820
 
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD