Truvada
- Product NDC
- 70518-0097
- 11-digit product format
- 705180097
- Labeler code
- 70518
- Product ID
- 70518-0097_df38be31-b767-7143-e053-2995a90a05c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA021752
- Marketing category
- NDA
- Marketing start
- 2016-12-30
- 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.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 70518-0097 | D | Discontinued by firm | 2026-10-02 | ||
| excluded package | package | 70518-0097 | 70518-0097-0 | D | Discontinued by firm | 2026-10-02 | |
| excluded package | package | 70518-0097 | 70518-0097-1 | D | Discontinued by firm | 2026-10-02 | |
| excluded package | package | 70518-0097 | 70518-0097-2 | D | Discontinued by firm | 2026-10-02 |
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.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-0097-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-0097-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-0097-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-0097-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-0097-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-0097-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0097-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0097-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-0097-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0097-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0097-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-0097-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0097-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0097-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-0097-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0097-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0097-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-0097-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0097-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0097-0 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-0097-1 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0097-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0097-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-0097-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0097-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0097-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-0097-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0097-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0097-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-0097-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0097-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0097-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-0097-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0097-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0097-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-0097-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021752-001 | TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 |
| N021752-002 | TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 |
| N021752-003 | TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 |
| N021752-004 | TRUVADA | EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021752-001 | AB |
| N021752-002 | AB |
| N021752-003 | AB |
| N021752-004 | AB |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021752-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021752-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021752-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021752-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021752-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021752-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021752-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021752-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021752-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021752-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-004 | AB | 1 | 5bbf6a4d5a75… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | 9457036 | 2024-01-13 | U-257 | Drug product | 2016-11-10 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021752-001 | 9744181 | 2024-01-13 | U-257 | Drug product | 2017-09-18 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | 9457036 | 2024-01-13 | U-257 | Drug product | 2016-11-10 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021752-001 | 9744181 | 2024-01-13 | U-257 | Drug product | 2017-09-18 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | 9457036 | 2024-01-13 | U-257 | Drug product | 2016-11-10 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021752-001 | 9744181 | 2024-01-13 | U-257 | Drug product | 2017-09-18 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | 9457036 | 2024-01-13 | U-257 | Drug product | 2016-11-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | 9744181 | 2024-01-13 | U-257 | Drug product | 2017-09-18 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | 9457036 | 2024-01-13 | U-257 | Drug product | 2016-11-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | 9744181 | 2024-01-13 | U-257 | Drug product | 2017-09-18 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021752-001 | 9457036 | 2024-01-13 | U-257 | Drug product | 2016-11-10 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021752-001 | 9744181 | 2024-01-13 | U-257 | Drug product | 2017-09-18 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021752-001 | 8592397 | 2024-01-13 | U-248 | Drug product | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021752-001 | 8592397 | 2024-01-13 | U-541 | Drug product | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021752-001 | 8592397 | 2024-01-13 | U-1170 | Drug product | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021752-001 | 8716264 | 2024-01-13 | U-257 | Drug product | 2014-05-30 | 301d65b070ca… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Truvada | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | Gilead Sciences, Inc | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 2025-07-16 | Boxed warning, Warnings, Adverse reactions | 021752 NDA021752 |
| Truvada | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | NuCare Pharmaceuticals,Inc. | 46e06df0-654d-43cc-e054-00144ff8d46c | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 021752 NDA021752 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70518-0097-0 | 70518009700 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0097-0) | 2016-12-30 | 0000-00-00 | No | No | Current |
| 70518-0097-1 | 70518009701 | 3 TABLET, FILM COATED in 1 BLISTER PACK (70518-0097-1) | 2017-02-22 | 0000-00-00 | No | No | Current |