Sulfamethoxazole and Trimethoprim
- Product NDC
- 70934-544
- 11-digit product format
- 709340544
- Labeler code
- 70934
- Product ID
- 70934-544_d8500916-caf6-2622-e053-2995a90ac5f8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Application
- ANDA090624
- Marketing category
- ANDA
- Marketing start
- 2020-02-12
- Marketing end
- 2026-12-31
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 800; 160 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
- Current FDA listing
- Yes
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 package | package | 70934-544 | 70934-544-10 | D | Discontinued by firm | 2026-10-12 | |
| excluded package | package | 70934-544 | 70934-544-28 | D | Discontinued by firm | 2026-10-12 |
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 | Code | Status | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70934-544-10 | D | Discontinued by firm | d630ba8d3edf… | 732f749b63fb… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… | |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70934-544-28 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70934-544-14 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70934-544-06 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70934-544-10 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 70934-544-20 | I | Inactivated by FDA | fb8cb913e6d1… | eb8c232b6be0… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded product | product | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… | |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70934-544-28 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70934-544-14 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70934-544-06 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70934-544-10 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-09 23:13 UTC · source 2022-04-08 | excluded package | package | 70934-544-20 | I | Inactivated by FDA | 86f5da6cb304… | a595104c45d7… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded product | product | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… | |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70934-544-28 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70934-544-14 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70934-544-06 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70934-544-10 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
| 2022-04-04 05:40 UTC · source 2022-04-01 | excluded package | package | 70934-544-20 | I | Inactivated by FDA | bd6a592717d7… | 303034d00443… |
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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sulfamethoxazole and Trimethoprim
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SULFAMETHOXAZOLE | 800 mg/1 |
| TRIMETHOPRIM | 160 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| JE42381TNV | Internal UNII lookup |
| AN164J8Y0X | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 198335 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a12bf393-d8ef-48df-e053-2a95a90a1af1 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 4ce811b5-329e-27f8-b5ff-66d52b435c00 | Product name | 3 | 20240108 |
| 8d30c4f0-0228-cea4-e3aa-f19064c47f27 | Product name | 3 | 20221128 |
| 6e20c430-5e8f-85da-1b03-f7dbc0c51fad | Product name | 3 | 20190926 |
| c1381fd7-868a-f499-ef90-8f6d3e3ee6b3 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Related label |
|---|---|---|
| 70934-544-06 | 2023-02-08 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-10 | 2023-02-08 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-14 | 2023-02-08 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-20 | 2023-02-08 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-28 | 2023-02-08 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-06 | 2022-01-28 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-10 | 2022-01-28 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-14 | 2022-01-28 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-20 | 2022-01-28 | Sulfamethoxazole and Trimethoprim Tablets, USP |
| 70934-544-28 | 2022-01-28 | Sulfamethoxazole and Trimethoprim Tablets, USP |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70934-544-06 | Sulfamethoxazole and Trimethoprim | 6 in 1 BOTTLE, PLASTIC | TABLET | 6 | 3 | |
| 70934-544-10 | Sulfamethoxazole and Trimethoprim | 10 in 1 BOTTLE, PLASTIC | TABLET | 10 | 3 | |
| 70934-544-14 | Sulfamethoxazole and Trimethoprim | 14 in 1 BOTTLE, PLASTIC | TABLET | 14 | 3 | |
| 70934-544-20 | Sulfamethoxazole and Trimethoprim | 20 in 1 BOTTLE, PLASTIC | TABLET | 20 | 3 | |
| 70934-544-28 | Sulfamethoxazole and Trimethoprim | 28 in 1 BOTTLE, PLASTIC | TABLET | 28 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70934-544-06 | EA - Each | 70934-544 | 149dcc40-87f2-4c93-86fe-6373ed434699 | 1 | 2023-01-09 |
| 70934-544-10 | EA - Each | 70934-544 | 96578738-51f7-4e59-b10f-856943cd5ce8 | 1 | 2023-01-09 |
| 70934-544-14 | EA - Each | 70934-544 | 76fd14bc-7170-447f-a53c-f7c0e0c26d45 | 1 | 2023-01-09 |
| 70934-544-20 | EA - Each | 70934-544 | 6a0434de-dc4d-433f-a37f-9db1705bb654 | 1 | 2022-03-09 |
| 70934-544-28 | EA - Each | 70934-544 | 81ca3049-ef15-4d18-8115-3e621e74dbe0 | 1 | 2023-01-09 |
DailyMed Dashboard NDC Coverage#
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 | American Health Packaging | 7f25bff3-0e86-4bec-b293-54b68347867f | 2025-07-23 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | PD-Rx Pharmaceuticals, Inc. | c4da9c4f-0704-4ed5-9d19-5c949f37f726 | 2025-04-30 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Cronus Pharma LLC | 1b5de94f-973a-4b5a-91d7-45e05be78650 | 2025-04-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Rising Pharma Holdings, Inc. | e1a3748d-ca73-4e56-95ad-d25189cc346e | 2025-04-02 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 62616708-a538-459f-9b7f-ed90c6aa5fc6 | 2025-04-01 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 14767ff8-7803-4922-ac03-ff80c061e5ba | 2025-03-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | fd90d8bd-1b84-4347-a98a-f8f94746f3e4 | 2025-03-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 4e12b7e1-fa2f-4cd1-ada6-19a7d5652348 | 2025-03-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | PD-Rx Pharmaceuticals, Inc. | 3ef62512-0dc3-4821-9b60-6b375841c4c0 | 2025-03-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Aurobindo Pharma Limited | 284b5dac-2b8d-46bf-95fe-80ce03fa178a | 2025-03-12 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 8c74ea5c-d05e-4fc1-b980-aacaab56d472 | 2025-02-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 20054147-811c-471a-8ec4-1b2903fe906e | 2025-02-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | a12fb7b0-9ff5-48f1-8fd9-4fbdfdbe09bc | 2025-02-26 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim DS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Advanced Rx Pharmacy of Tennessee, LLC | afe8cb1c-7cfd-3378-e053-2a95a90a4db6 | 2024-12-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim DS | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Advanced Rx Pharmacy of Tennessee, LLC | b000150f-3be6-2e6c-e053-2995a90a67d5 | 2024-12-31 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Quality Care Products LLC | 079c828c-148f-45b9-966e-d8906043b2a2 | 2024-12-17 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | A-S Medication Solutions | 7d7ca48b-8655-4cfb-8db0-28eddf1feb9b | 2024-10-25 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Bryant Ranch Prepack | 27bebe39-c069-4a9d-99d1-c7cf44ac2f41 | 2024-10-07 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals, Inc. | 3ed6bf70-2841-04f8-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | 090624 ANDA090624 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | NuCare Pharmaceuticals, Inc. | 46dc8f62-e700-50e3-e054-00144ff8d46c | 2024-08-14 | Warnings, Adverse reactions | 090624 ANDA090624 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | a12bf393-d8ef-48df-e053-2a95a90a1af1 | 3 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | a12bf393-d8ef-48df-e053-2a95a90a1af1 | 3 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | a12bf393-d8ef-48df-e053-2a95a90a1af1 | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70934-544-06 | 70934054406 | 6 TABLET in 1 BOTTLE, PLASTIC (70934-544-06) | 6 tablet | 2020-02-12 | 2026-12-31 | No | No | Current |
| 70934-544-10 | 70934054410 | 10 TABLET in 1 BOTTLE, PLASTIC (70934-544-10) | 10 tablet | 2020-02-13 | 0000-00-00 | No | No | Current |
| 70934-544-14 | 70934054414 | 14 TABLET in 1 BOTTLE, PLASTIC (70934-544-14) | 14 tablet | 2020-02-18 | 2026-12-31 | No | No | Current |
| 70934-544-20 | 70934054420 | 20 TABLET in 1 BOTTLE, PLASTIC (70934-544-20) | 20 tablet | 2020-02-18 | 2026-12-31 | No | No | Current |
| 70934-544-28 | 70934054428 | 28 TABLET in 1 BOTTLE, PLASTIC (70934-544-28) | 28 tablet | 2020-03-19 | 0000-00-00 | No | No | Current |