Truvada
- Product NDC
- 61958-0701
- 11-digit product format
- 619580701
- Labeler code
- 61958
- Product ID
- 61958-0701_32422ee8-1cdc-4305-bb3e-0458472513fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- emtricitabine and tenofovir disoproxil fumarate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Gilead Sciences, Inc
- Application
- NDA021752
- Marketing category
- NDA
- Marketing start
- 2004-08-02
- Substance
- EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
- Active strength
- 200; 300 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
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | TRUVADA | 200MG;300MG | TABLET / ORAL | AB | RLD, RS | 2004-08-02 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-002 | TRUVADA | 100MG;150MG | TABLET / ORAL | AB | RLD | 2016-03-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-003 | TRUVADA | 133MG;200MG | TABLET / ORAL | AB | RLD | 2016-03-10 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-004 | TRUVADA | 167MG;250MG | TABLET / ORAL | AB | RLD | 2016-03-10 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 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… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021752-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021752-004 | AB | 1 | d06236e962d9… |
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… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Truvada
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| EMTRICITABINE | 200 mg/1 |
| TENOFOVIR DISOPROXIL FUMARATE | 300 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| OTT9J7900I | Internal UNII lookup |
| G70B4ETF4S | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 476556 | Internal RxNorm lookup |
| 639888 | Internal RxNorm lookup |
| 1744001 | Internal RxNorm lookup |
| 1744003 | Internal RxNorm lookup |
| 1744005 | Internal RxNorm lookup |
| 1744007 | Internal RxNorm lookup |
| 1744009 | Internal RxNorm lookup |
| 1744011 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 54e82b13-a037-49ed-b4b3-030b37c0ecdd | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61958-0701-1 | Truvada | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED | 30 | 32 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61958-0701-1 | EA - Each | 61958-0701 | cc7bbfc2-fa7f-449b-9d65-39983da377d8 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61958-0701 | TRUVADA (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC] | 31 | Current NDC, Legacy NDC, 1 package rows | 20240524_54e82b13-a037-49ed-b4b3-030b37c0ecdd.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.
| 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 61958-0701 |
| Truvada | EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE | NuCare Pharmaceuticals,Inc. | 46e06df0-654d-43cc-e054-00144ff8d46c | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | 021752 NDA021752 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1744001 | emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744005 | emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744009 | emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744003 | Truvada 100 MG / 150 MG Oral tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744007 | Truvada 133 MG / 200 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744011 | Truvada 167 MG / 250 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744003 | emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet [Truvada] | SBD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744007 | emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet [Truvada] | SBD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744011 | emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet [Truvada] | SBD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744001 | emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG Oral Tablet | SCD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744005 | emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG Oral Tablet | SCD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744009 | emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG Oral Tablet | SCD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744001 | emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744005 | emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744009 | emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744003 | Truvada (emtricitabine 100 MG / tenofovir disoproxil fumarate 150 MG (equivalent to tenofovir disoproxil 123 MG)) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744007 | Truvada (emtricitabine 133 MG / tenofovir disoproxil fumarate 200 MG (equivalent to tenofovir disoproxil 163 MG)) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744011 | Truvada (emtricitabine 167 MG / tenofovir disoproxil fumarate 250 MG (equivalent to tenofovir disoproxil 204 MG)) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 1744003 | Truvada 100 MG / 150 MG Oral tablet | SY | 54e82b13-a037-49ed-b4b3-030b37c0ecdd | 32 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 00b4b5b5-7220-410c-8db2-dd940498cfc2 | 12 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | 00b4b5b5-7220-410c-8db2-dd940498cfc2 | 12 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | 00b4b5b5-7220-410c-8db2-dd940498cfc2 | 12 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 00b4b5b5-7220-410c-8db2-dd940498cfc2 | 12 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 00b4b5b5-7220-410c-8db2-dd940498cfc2 | 12 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 00b4b5b5-7220-410c-8db2-dd940498cfc2 | 12 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 46e06df0-654d-43cc-e054-00144ff8d46c | 5 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | 46e06df0-654d-43cc-e054-00144ff8d46c | 5 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | 46e06df0-654d-43cc-e054-00144ff8d46c | 5 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 46e06df0-654d-43cc-e054-00144ff8d46c | 5 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 46e06df0-654d-43cc-e054-00144ff8d46c | 5 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 46e06df0-654d-43cc-e054-00144ff8d46c | 5 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 4f4268c2-42aa-49fa-e054-00144ff88e88 | 4 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 4f4268c2-42aa-49fa-e054-00144ff88e88 | 4 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 4f4268c2-42aa-49fa-e054-00144ff88e88 | 4 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | b34cb984-313c-4be3-b34e-90ab2797a29e | 2 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 7fbc31c3-48d3-4508-8717-1cdfbf085b4d | 2 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | b34cb984-313c-4be3-b34e-90ab2797a29e | 2 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | 7fbc31c3-48d3-4508-8717-1cdfbf085b4d | 2 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | b34cb984-313c-4be3-b34e-90ab2797a29e | 2 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | 7fbc31c3-48d3-4508-8717-1cdfbf085b4d | 2 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 7fbc31c3-48d3-4508-8717-1cdfbf085b4d | 2 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | b34cb984-313c-4be3-b34e-90ab2797a29e | 2 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | b34cb984-313c-4be3-b34e-90ab2797a29e | 2 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 7fbc31c3-48d3-4508-8717-1cdfbf085b4d | 2 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 7fbc31c3-48d3-4508-8717-1cdfbf085b4d | 2 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | b34cb984-313c-4be3-b34e-90ab2797a29e | 2 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | PSN | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 | 1 |
| 639888 | Truvada 200 MG / 300 MG Oral Tablet | PSN | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 | 1 |
| 639888 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet [Truvada] | SBD | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG Oral Tablet | SCD | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 | 1 |
| 476556 | emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG) Oral Tablet | SY | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | 032f734e-4969-46ae-a3b6-d8dcb4ccc482 | 1 |
| 639888 | Truvada (emtricitabine 200 MG / tenofovir disoproxil fumarate 300 MG (equivalent to tenofovir disoproxil 245 MG)) Oral Tablet | SY | d0b3d18b-7e5d-49ea-bcaf-8408414e8094 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 61958-0701-1 | 61958070101 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-0701-1) | 2004-08-02 | 0000-00-00 | No | No | Current |