Truvada

Product NDC
63629-7581
11-digit product format
636297581
Labeler code
63629
Product ID
63629-7581_bfbe19cd-eb95-44b8-ad2e-34fb7f50d455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
emtricitabine and tenofovir disoproxil fumarate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA021752
Marketing category
NDA
Marketing start
2004-08-02
Marketing end
0000-00-00
Substance
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Active strength
200 mg/1; mg/1
Pharmacologic classes
Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleosides [CS], Nucleosides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-7581DDiscontinued by firm2026-08-11
excluded packagepackage63629-758163629-7581-1DDiscontinued by firm2026-08-11
excluded packagepackage63629-758163629-7581-2DDiscontinued by firm2026-08-11
excluded packagepackage63629-758163629-7581-3DDiscontinued by firm2026-08-11

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 · 59 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7581-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7581-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7581-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7581-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7581-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7581-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7581-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7581-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7581-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7581-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7581-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7581-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7581-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7581-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7581-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7581-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7581-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7581-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7581-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7581-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7581-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7581-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7581-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7581-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7581-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7581-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7581-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7581-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7581-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7581-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7581-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7581-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7581-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7581-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7581-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7581-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7581-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7581-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage63629-7581-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7581-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7581-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage63629-7581-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7581-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7581-1IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
N021752-001TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE200MG;300MGTABLET / ORALABRLD, RS2004-08-02
N021752-002TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE100MG;150MGTABLET / ORALABRLD2016-03-10
N021752-003TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE133MG;200MGTABLET / ORALABRLD2016-03-10
N021752-004TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE167MG;250MGTABLET / ORALABRLD2016-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021752-001AB
N021752-002AB
N021752-003AB
N021752-004AB

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 UTC2026-02N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021752-001TRUVADA200MG;300MGTABLET / ORALABRLD, RS2004-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-002TRUVADA100MG;150MGTABLET / ORALABRLD2016-03-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-003TRUVADA133MG;200MGTABLET / ORALABRLD2016-03-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-004TRUVADA167MG;250MGTABLET / ORALABRLD2016-03-10d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 146 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021752-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021752-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021752-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021752-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021752-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021752-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021752-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021752-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021752-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021752-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021752-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021752-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-004AB1d06236e962d9…

Observed Orange Book patent history#

Patent history page 1 of 10 · 390 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-00185923972024-01-13U-248Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-00185923972024-01-13U-541Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-00185923972024-01-13U-1170Drug product03ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-00187162642024-01-13U-257Drug product2014-05-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-00194570362024-01-13U-257Drug product2016-11-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021752-00197441812024-01-13U-257Drug product2017-09-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-00185923972024-01-13U-248Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-00185923972024-01-13U-541Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-00185923972024-01-13U-1170Drug product2680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-00187162642024-01-13U-257Drug product2014-05-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-00194570362024-01-13U-257Drug product2016-11-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021752-00197441812024-01-13U-257Drug product2017-09-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-00185923972024-01-13U-248Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-00185923972024-01-13U-541Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-00185923972024-01-13U-1170Drug product5bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-00187162642024-01-13U-257Drug product2014-05-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-00194570362024-01-13U-257Drug product2016-11-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021752-00197441812024-01-13U-257Drug product2017-09-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-00185923972024-01-13U-248Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-00185923972024-01-13U-541Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-00185923972024-01-13U-1170Drug productd8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-00187162642024-01-13U-257Drug product2014-05-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-00194570362024-01-13U-257Drug product2016-11-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021752-00197441812024-01-13U-257Drug product2017-09-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021752-00185923972024-01-13U-248Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-00185923972024-01-13U-541Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-00185923972024-01-13U-1170Drug productd06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-00187162642024-01-13U-257Drug product2014-05-30d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-00194570362024-01-13U-257Drug product2016-11-10d06236e962d9…
2024-10-29 15:01 UTC2024-10N021752-00197441812024-01-13U-257Drug product2017-09-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021752-00185923972024-01-13U-248Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021752-00185923972024-01-13U-541Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021752-00185923972024-01-13U-1170Drug product79d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021752-00187162642024-01-13U-257Drug product2014-05-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021752-00194570362024-01-13U-257Drug product2016-11-1079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021752-00197441812024-01-13U-257Drug product2017-09-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021752-00185923972024-01-13U-248Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021752-00185923972024-01-13U-541Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021752-00185923972024-01-13U-1170Drug product301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021752-00187162642024-01-13U-257Drug product2014-05-30301d65b070ca…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7581-12024-05-16These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-22024-05-16These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-32024-05-16These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-12024-01-30These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-22024-01-30These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-32024-01-30These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-12020-07-06These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-22020-07-06These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-12020-01-31These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004
63629-7581-22020-01-31These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA ® (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2004

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TruvadaEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc54e82b13-a037-49ed-b4b3-030b37c0ecdd2025-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021752
application number: NDA021752
TruvadaEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENuCare Pharmaceuticals,Inc.46e06df0-654d-43cc-e054-00144ff8d46c2024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021752
application number: NDA021752

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7581-1636297581013 TABLET, FILM COATED in 1 BOTTLE (63629-7581-1) 2018-04-240000-00-00NoNoCurrent
63629-7581-2636297581027 TABLET, FILM COATED in 1 BOTTLE (63629-7581-2) 2018-04-240000-00-00NoNoCurrent
63629-7581-36362975810315 TABLET, FILM COATED in 1 BOTTLE (63629-7581-3) 2018-04-240000-00-00NoNoCurrent