Sulfamethoxazole and Trimethoprim
- Product NDC
- 68788-7122
- 11-digit product format
- 687887122
- Labeler code
- 68788
- Product ID
- 68788-7122_0d5fd38d-9ffe-4dca-9d05-286ed451752f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090624
- Marketing category
- ANDA
- Marketing start
- 2019-01-14
- Marketing end
- 0000-00-00
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 800 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 | 68788-7122 | D | Discontinued by firm | 2026-09-14 | ||
| excluded package | package | 68788-7122 | 68788-7122-1 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68788-7122 | 68788-7122-2 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68788-7122 | 68788-7122-3 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68788-7122 | 68788-7122-4 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68788-7122 | 68788-7122-6 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68788-7122 | 68788-7122-7 | D | Discontinued by firm | 2026-09-14 | |
| excluded package | package | 68788-7122 | 68788-7122-8 | D | Discontinued by firm | 2026-09-14 |
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.
| Dataset | Scope | Package NDC |
|---|---|---|
| excluded product | product | |
| excluded package | package | 68788-7122-6 |
| excluded package | package | 68788-7122-3 |
| excluded package | package | 68788-7122-7 |
| excluded package | package | 68788-7122-8 |
| excluded package | package | 68788-7122-1 |
| excluded package | package | 68788-7122-2 |
| excluded package | package | 68788-7122-4 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | |
| A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090624-001 | AB |
| A090624-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 400MG;80MG | TABLET / ORAL | AB | 2010-02-16 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 800MG;160MG | TABLET / ORAL | AB | 2010-02-16 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090624-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A090624-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090624-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A090624-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A090624-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090624-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A090624-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090624-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090624-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090624-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090624-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090624-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090624-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A090624-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090624-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090624-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090624-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A090624-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090624-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A090624-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A090624-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A090624-002 | AB | 1 | 74a2ff9319b5… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68788-7122-1 | EA - Each | 68788-7122 | 147c7ccf-90fb-46fb-80cf-74d410a9e4ee | 1 | 2019-04-11 |
| 68788-7122-2 | EA - Each | 68788-7122 | 0e449a1c-11a9-40ad-b97b-1b1fdf500047 | 1 | 2019-04-11 |
| 68788-7122-3 | EA - Each | 68788-7122 | b0516900-0d73-4689-98c4-cfd1dbe425f7 | 1 | 2019-04-11 |
| 68788-7122-4 | EA - Each | 68788-7122 | 557eeee4-83c9-44bf-9414-c021b9f1bd6e | 1 | 2019-04-11 |
| 68788-7122-6 | EA - Each | 68788-7122 | e289e9de-7198-4c0c-9865-e276449162d9 | 1 | 2019-04-11 |
| 68788-7122-7 | EA - Each | 68788-7122 | 1316f2b4-6391-4c78-8e3b-7a8a5bcd8af2 | 1 | 2019-04-11 |
| 68788-7122-8 | EA - Each | 68788-7122 | 0e0a4732-0fe5-472a-82ef-f5a732fdabb9 | 1 | 2019-04-11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68788-7122 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS INC.] | 7 | Legacy NDC | 20240816_89106587-6e58-4611-8d8e-43dc46472442.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 |
|---|---|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Preferred Pharmaceuticals Inc. | d60c218c-6529-4944-af0b-a9dc720f32e9 | 2026-09-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | ce44959b-4bfe-4ba9-9fc2-7f9d4663d542 | 2026-08-10 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | ec2e335c-3357-40d8-9615-a09fc40ce5f4 | 2026-08-07 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | c45ac3a4-d397-486e-abd1-349916543068 | 2026-07-27 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Cardinal Health 107, LLC | 08500fcb-dbec-4ac2-91c3-189d27907ec0 | 2026-07-17 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Unit Dose Solutions, Inc. | 562e2547-db2d-e2d2-e063-6294a90a1f5d | 2026-07-09 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | St. Mary's Medical Park Pharmacy | e3a49508-0ebe-1334-e053-2a95a90ae173 | 2026-06-11 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Coupler LLC | 518cc045-a12b-f08f-e063-6394a90acb0c | 2026-05-11 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | AvPAK | 29df8839-3dfa-0b2b-c5a3-906db6997b3b | 2026-03-24 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 75b9d194-b960-4943-bedc-96e3d65c4da9 | 2026-03-03 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 7f82e5e0-b627-a3f3-e053-2991aa0abaa5 | 2026-02-09 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Sportpharm LLC | 52304e5e-d097-48f2-8b64-210908e4eb54 | 2026-02-03 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | REMEDYREPACK INC. | 99e1ace6-7665-4f87-82fd-5e7c4989e098 | 2026-01-13 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfameth/Trimeth-DS | SULFAMETH/TRIMETH-DS | Direct_Rx | 90026ce8-3305-6272-e053-2995a90a57e0 | 2026-01-08 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 8c3e4738-0e0a-a854-e053-2995a90a7d71 | 2026-01-05 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Northwind Health Company, LLC | f7f97520-d063-ec87-e053-6294a90aae0c | 2026-01-01 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Northwind Health Company, LLC | 471c5995-a4df-fbe3-e063-6394a90aa50e | 2025-12-29 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | QPharma, Inc. | 41529314-b203-47f4-88dd-5aa57c74985f | 2025-12-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | VERITYRX, LLC | 427b8040-99a4-8e81-e063-6394a90a76c5 | 2025-10-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals,Inc. | 1274cefb-0799-e2e4-e063-6394a90aad02 | 2025-10-07 | Warnings, Adverse reactions | 090624 ANDA090624 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68788-7122-1 | 68788712201 | 10 TABLET in 1 BOTTLE (68788-7122-1) | 10 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 68788-7122-2 | 68788712202 | 20 TABLET in 1 BOTTLE (68788-7122-2) | 20 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 68788-7122-3 | 68788712203 | 30 TABLET in 1 BOTTLE (68788-7122-3) | 30 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 68788-7122-4 | 68788712204 | 14 TABLET in 1 BOTTLE (68788-7122-4) | 14 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 68788-7122-6 | 68788712206 | 6 TABLET in 1 BOTTLE (68788-7122-6) | 6 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 68788-7122-7 | 68788712207 | 28 TABLET in 1 BOTTLE (68788-7122-7) | 28 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |
| 68788-7122-8 | 68788712208 | 40 TABLET in 1 BOTTLE (68788-7122-8) | 40 tablet | 2019-01-14 | 0000-00-00 | No | No | Current |