Tenofovir Disoproxil Fumarate

Product NDC
60687-366
11-digit product format
606870366
Labeler code
60687
Product ID
60687-366_99821195-e91e-3e4d-e053-2995a90ab933
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tenofovir Disoproxil Fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090647
Marketing category
ANDA
Marketing start
2018-05-01
Marketing end
2020-03-31
Substance
TENOFOVIR DISOPROXIL FUMARATE
Active strength
300 mg/1
Pharmacologic classes
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleosides [CS],Nucleoside Reverse Transcriptase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct60687-366DDiscontinued by firm2026-08-17
excluded packagepackage60687-36660687-366-25DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage60687-366-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60687-366-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60687-366-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60687-366-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60687-366-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60687-366-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60687-366-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60687-366-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60687-366-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60687-366-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60687-366-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60687-366-25557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090647-001TENOFOVIR DISOPROXIL FUMARATE150MGTABLET / ORALAB2018-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090647-002TENOFOVIR DISOPROXIL FUMARATE200MGTABLET / ORALAB2018-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090647-003TENOFOVIR DISOPROXIL FUMARATE250MGTABLET / ORALAB2018-01-26caaa826d4ba7…
2026-08-18 06:07:402026-07A090647-004TENOFOVIR DISOPROXIL FUMARATE300MGTABLET / ORALAB2018-01-26caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090647-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090647-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090647-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090647-004AB1caaa826d4ba7…
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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-366-25EA - Each60687-3665784a0aa-0443-4b6c-a21b-e95217a2465e12018-06-11
60687-366-95EA - Each60687-366c4dbb0f2-4e5f-436c-90b4-96a063bd4a4712018-06-11

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