tenofovir disoproxil fumarate

Manufacturer
AIZANT DRUG RESEARCH SOLUTIONS PVT LTD
Effective date
2015-08-20
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:25:20

Label at a glance#

Producttenofovir disoproxil fumarate
Active ingredienttenofovir disoproxil fumarate
Label structure2 sections

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 disoproxiltab...

Label contents#

Full prescribing information#

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

SPL UNCLASSIFIED SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 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, 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, 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 Tablets, 300 mg Container Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1243324tenofovir disoproxil fumarate 150 MG Oral TabletPSN1
1243328tenofovir disoproxil fumarate 200 MG Oral TabletPSN1
1243227tenofovir disoproxil fumarate 250 MG Oral TabletPSN1
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSN1
1243324tenofovir disoproxil fumarate 150 MG Oral TabletSCD1
1243328tenofovir disoproxil fumarate 200 MG Oral TabletSCD1
1243227tenofovir disoproxil fumarate 250 MG Oral TabletSCD1
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCD1
1243324tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSY1
1243328tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSY1
1243227tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSY1
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
TENOFOVIR ANHYDROUS Pharmacologic Class Indexing6Indexing - Pharmacologic Class20200302

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33cd1557-9629-1a35-1f2f-499cf7c608bcProduct name220260305
5f93de8c-a439-4aaa-862f-7cf2524cb240Product name320250812
6286e356-28a5-4b4b-a174-76bf53b211e3Product name620250121
233e3f87-da6c-4b7d-80cb-963ca3258270Product name220240419
c0c98dbe-5e23-74e9-f9fc-07af05f77d95Product name820240319
4ef90d80-1289-4267-a2bb-01c741d1208fProduct name120230829
72dcca4e-6eae-4149-a92b-264c2a07004fProduct name120230808
1cd1fd33-94db-4c45-bd26-82773ea350a3Product name220220317
14397d46-1c8c-bbf7-f4b7-5a7e59d3690fProduct name420220314
320f244d-8b4e-4893-9f14-104b2a8e0aafProduct name220201007
7ff71f22-5b66-4a3d-bf64-671893a6409dProduct name220201007
6f122144-2ceb-48fa-a906-0d2eb742717eProduct name120190624
8051c8a3-aee0-45a2-a236-8ee3f9e65f67Product name120181211
a56d673d-fa42-4b0e-b5ce-e65a5eab34b7Product name120180911
d1784558-3c5f-4d73-8a7c-051102bb6c92Product name120160405
7fd46899-3505-4ed4-b856-6b2509a76004Product name120151123
0583b5e6-2e6e-c94b-9ff6-81a81ba199deProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69025-100-01tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED301
69025-101-01tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED301
69025-102-01tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED301
69025-103-01tenofovir disoproxil fumarate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69025-100TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AIZANT DRUG RESEARCH SOLUTIONS PVT LTD]1Legacy NDC, 1 package rows20180126_79b774fe-abcd-47b4-943b-e82fc87bd6df.zip
69025-101TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AIZANT DRUG RESEARCH SOLUTIONS PVT LTD]1Legacy NDC, 1 package rows20180126_79b774fe-abcd-47b4-943b-e82fc87bd6df.zip
69025-102TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AIZANT DRUG RESEARCH SOLUTIONS PVT LTD]1Legacy NDC, 1 package rows20180126_79b774fe-abcd-47b4-943b-e82fc87bd6df.zip
69025-103TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AIZANT DRUG RESEARCH SOLUTIONS PVT LTD]1Legacy NDC, 1 package rows20180126_79b774fe-abcd-47b4-943b-e82fc87bd6df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
e23a06d9-5379-462e-9cb0-9462086c5f3d79b774fe-abcd-47b4-943b-e82fc87bd6df2015-08-20Exact identifier
spl id: e23a06d9-5379-462e-9cb0-9462086c5f3d
spl set id: 79b774fe-abcd-47b4-943b-e82fc87bd6df