Sulfamethoxazole and Trimethoprim
- Product NDC
- 55289-457
- 11-digit product format
- 552890457
- Labeler code
- 55289
- Product ID
- 55289-457_d9f63b39-f83e-d396-e053-2995a90ad48f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA076899
- Marketing category
- ANDA
- Marketing start
- 2010-02-25
- Marketing end
- 0000-00-00
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 400 mg/1; mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [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 | 55289-457 | D | Discontinued by firm | 2026-08-11 | ||
| excluded package | package | 55289-457 | 55289-457-10 | D | Discontinued by firm | 2026-08-11 | |
| excluded package | package | 55289-457 | 55289-457-20 | D | Discontinued by firm | 2026-08-11 |
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.
| 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 | 55289-457-20 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 55289-457-10 | 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 | 55289-457-20 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 55289-457-10 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | |
| A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076899-001 | AB |
| A076899-002 | 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 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076899-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2005-01-27 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076899-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2005-01-27 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076899-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076899-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076899-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076899-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076899-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076899-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076899-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076899-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076899-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076899-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A076899-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076899-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076899-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076899-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A076899-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076899-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A076899-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A076899-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076899-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076899-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A076899-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076899-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A076899-002 | AB | 1 | 782e0a99824c… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55289-457-10 | EA - Each | 55289-457 | 2737b829-01c4-4a54-928c-e6f80c46b405 | 1 | 2012-07-24 |
| 55289-457-20 | EA - Each | 55289-457 | 97474e7e-84ea-4001-942e-cad74c5227ae | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SULFAMETHOXAZOLE | ACTIVE INGREDIENT | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| TRIMETHOPRIM | ACTIVE INGREDIENT | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| SULFAMETHOXAZOLE | ACTIVE MOIETY | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| TRIMETHOPRIM | ACTIVE MOIETY | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PD-RX PHARMACEUTICALS, INC.] | 4 |
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 |
|---|---|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Amneal Pharmaceuticals LLC | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 2026-04-02 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | AvKARE | 9f130443-c8e7-9122-8f27-f72f07f3f29e | 2026-02-10 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Northwind Health Company, LLC | f2b8e9d9-1274-22ca-e053-2a95a90a6f1a | 2026-01-01 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Cardinal Health 107, LLC | 5dc03027-cdaf-461f-87fd-630d382fc723 | 2025-11-21 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Major Pharmaceuticals | abe0d2d5-4879-4b4e-9b57-47ea83a17ba0 | 2025-11-18 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d | 2025-05-15 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Amneal Pharmaceuticals of New York LLC | 3233c54d-484d-4550-b172-db8af47d1b7f | 2025-02-26 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim DS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Advanced Rx Pharmacy of Tennessee, LLC | b001e648-2710-3ada-e053-2995a90a52f1 | 2024-12-31 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Bryant Ranch Prepack | a174991a-53e7-c791-3cee-b706a48e0ec5 | 2024-10-09 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | f39a4c93-0a0e-4801-aecc-c55a2fa5e68b | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | ffc5d594-429c-4303-b3b6-f5a83e915b55 | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 07a49665-fe2a-4a92-a57e-49db224b012e | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 8661e318-ddf3-4a60-8781-6fa42307c60a | 2024-01-08 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | b85a58a7-74d6-4629-8027-0cdcbb5c815a | 2023-12-17 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 07da67b1-b50c-4471-8cde-8a119eb8c935 | 2023-12-15 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethox-TMP DS | SULFAMETHOXAZOLE, TRIMETHOPRIM | PharmPak, Inc. | ede74118-32c5-4f52-9823-509538e674c8 | 2022-10-09 | Warnings, Adverse reactions | 076899 ANDA076899 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Proficient Rx LP | 0df74ba1-1aa6-467c-92e7-6b017c7c6bce | 2019-11-01 | Warnings, Adverse reactions | 076899 ANDA076899 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55289-457-10 | 55289045710 | 10 TABLET in 1 BOTTLE, PLASTIC (55289-457-10) | 10 tablet | 2011-05-05 | 0000-00-00 | No | No | Current |
| 55289-457-20 | 55289045720 | 20 TABLET in 1 BOTTLE, PLASTIC (55289-457-20) | 20 tablet | 2011-05-05 | 0000-00-00 | No | No | Current |