FDA.reportPublic FDA data

Tenofovir Disoproxil Fumarate

Product NDC
65862-818
11-digit product format
658620818
Labeler code
65862
Product ID
65862-818_ab772f55-3f84-41df-a84f-3a7035602cfd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA090647
Marketing category
ANDA
Marketing start
2018-01-26
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
150 mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090647-001TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26
A090647-002TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26
A090647-003TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26
A090647-004TENOFOVIR DISOPROXIL FUMARATETENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090647-001AB
A090647-002AB
A090647-003AB
A090647-004AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090647-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090647-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090647-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090647-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090647-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090647-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090647-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090647-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090647-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090647-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090647-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090647-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090647-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Tenofovir Disoproxil Fumarate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TENOFOVIR DISOPROXIL FUMARATE150 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
OTT9J7900IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349251Internal RxNorm lookup
1243227Internal RxNorm lookup
1243324Internal RxNorm lookup
1243328Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a75c6be8-3719-4bb3-8a9e-06e5254d2a82Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-818-03Tenofovir Disoproxil Fumarate10 in 1 BLISTER PACKTABLET, FILM COATED1018
65862-818-03Tenofovir Disoproxil Fumarate3 in 1 CARTONTABLET, FILM COATED318
65862-818-30Tenofovir Disoproxil Fumarate30 in 1 BOTTLETABLET, FILM COATED3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-818TENOFOVIR DISOPROXIL FUMARATE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]18Current NDC, Legacy NDC, 3 package rows20240608_a75c6be8-3719-4bb3-8a9e-06e5254d2a82.zip

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
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEAurobindo Pharma Limiteda75c6be8-3719-4bb3-8a9e-06e5254d2a822024-06-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090647
application number: ANDA090647
ndc (product): 65862-818

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1243324tenofovir disoproxil fumarate 150 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243328tenofovir disoproxil fumarate 200 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243227tenofovir disoproxil fumarate 250 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
349251tenofovir disoproxil fumarate 300 MG Oral TabletPSNa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243324tenofovir disoproxil fumarate 150 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243328tenofovir disoproxil fumarate 200 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243227tenofovir disoproxil fumarate 250 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
349251tenofovir disoproxil fumarate 300 MG Oral TabletSCDa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243324tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243328tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
1243227tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218
349251tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral TabletSYa75c6be8-3719-4bb3-8a9e-06e5254d2a8218

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-818-03658620818033 BLISTER PACK in 1 CARTON (65862-818-03) / 10 TABLET, FILM COATED in 1 BLISTER PACK3 blister pack2018-01-260000-00-00NoNoCurrent
65862-818-306586208183030 TABLET, FILM COATED in 1 BOTTLE (65862-818-30) 2018-01-260000-00-00NoNoCurrent