Sulfamethoxazole and Trimethoprim
- Product NDC
- 17856-5181
- 11-digit product format
- 178565181
- Labeler code
- 17856
- Product ID
- 17856-5181_4b1ecd4a-5752-4ef8-8946-2abcb60e86ab
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA077785
- Marketing category
- ANDA
- Marketing start
- 2007-01-24
- Marketing end
- 0000-00-00
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 200 mg/5mL; mg/5mL
- Pharmacologic classes
- Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- 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 | 17856-5181 | I | Inactivated by FDA | 2026-08-11 | ||
| excluded package | package | 17856-5181 | 17856-5181-1 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 17856-5181 | 17856-5181-2 | I | Inactivated by FDA | 2026-08-11 | |
| excluded package | package | 17856-5181 | 17856-5181-3 | I | Inactivated by FDA | 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 | 17856-5181-2 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-5181-1 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-5181-1 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-5181-1 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-5181-1 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 17856-5181-1 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 17856-5181-1 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 17856-5181-1 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 17856-5181-1 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 17856-5181-1 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 17856-5181-1 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 17856-5181-1 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 17856-5181-3 | 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 | 17856-5181-2 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 17856-5181-1 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 17856-5181-3 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded product | product | 8af77b9d5b6f… | d9bbb34c5368… | |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 17856-5181-2 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 17856-5181-1 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | excluded package | package | 17856-5181-3 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded product | product | 834df4deac94… | adcc014656a3… | |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 17856-5181-2 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 17856-5181-1 | 834df4deac94… | adcc014656a3… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | excluded package | package | 17856-5181-3 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded product | product | 1332a3947898… | d4bfe170f9cd… | |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 17856-5181-2 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 17856-5181-1 | 1332a3947898… | d4bfe170f9cd… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | excluded package | package | 17856-5181-3 | 1332a3947898… | d4bfe170f9cd… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | SULFAMETHOXAZOLE; TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A077785-001 | 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 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077785-001 | SULFAMETHOXAZOLE AND TRIMETHOPRIM | 200MG/5ML;40MG/5ML | SUSPENSION / ORAL | AB | 2007-01-24 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A077785-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077785-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A077785-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077785-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077785-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077785-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077785-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077785-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077785-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A077785-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077785-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077785-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077785-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A077785-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077785-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077785-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077785-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077785-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077785-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077785-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077785-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077785-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077785-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077785-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077785-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077785-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077785-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077785-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077785-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077785-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077785-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077785-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077785-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077785-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077785-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077785-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077785-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077785-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077785-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077785-001 | AB | 1 | cb3db0bc1861… |
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 | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-5181-1 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-647a-a426-e053-dadaa90af4c2 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only |
| 17856-5181-2 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-647a-a426-e053-dadaa90af4c2 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only |
| 17856-5181-3 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-647a-a426-e053-dadaa90af4c2 | Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg/40 mg per 5 mL Rx only |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-5181-1 | Sulfamethoxazole and Trimethoprim | 5 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 5 | 1 | |
| 17856-5181-1 | Sulfamethoxazole and Trimethoprim | 72 in 1 BOX, UNIT-DOSE | SUSPENSION | 72 | 1 | |
| 17856-5181-2 | Sulfamethoxazole and Trimethoprim | 10 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 10 | 1 | |
| 17856-5181-2 | Sulfamethoxazole and Trimethoprim | 72 in 1 BOX, UNIT-DOSE | SUSPENSION | 72 | 1 | |
| 17856-5181-3 | Sulfamethoxazole and Trimethoprim | 20 mL in 1 CUP, UNIT-DOSE | SUSPENSION | 20 | 1 | |
| 17856-5181-3 | Sulfamethoxazole and Trimethoprim | 50 in 1 BOX, UNIT-DOSE | SUSPENSION | 50 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-5181 | SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [ATLANTIC BIOLOGICALS CORP.] | 1 | Legacy NDC, 6 package rows | 20201028_e2a018ad-31aa-47d2-b96b-e7a1deee0976.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 | Chartwell Governmental & Specialty RX, LLC. | 2a5173ba-047d-4a80-81fb-7154265ae3d1 | 2026-02-24 | Warnings, Adverse reactions | 077785 ANDA077785 |
| Sulfamethoxazole and Trimethoprim | SULFAMETHOXAZOLE AND TRIMETHOPRIM | Chartwell RX, LLC | b5b7aba5-f93d-46bc-a3c2-712de1c5cff3 | 2025-03-28 | Warnings, Adverse reactions | 077785 ANDA077785 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 313134 | sulfamethoxazole 200 MG / trimethoprim 40 MG in 5 mL Oral Suspension | PSN | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 40 MG/ML / trimethoprim 8 MG/ML Oral Suspension | SCD | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | SMX 40 MG/ML / TMP 8 MG/ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 100 MG / trimethoprim 20 MG per 2.5 ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 200 MG / trimethoprim 40 MG per 5 ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
| 313134 | sulfamethoxazole 800 MG / trimethoprim 160 MG per 20 ML Oral Suspension | SY | e2a018ad-31aa-47d2-b96b-e7a1deee0976 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 17856-5181-1 | 17856518101 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-1) > 5 mL in 1 CUP, UNIT-DOSE | 2020-10-27 | 0000-00-00 | No | No | Current |
| 17856-5181-2 | 17856518102 | 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-2) > 10 mL in 1 CUP, UNIT-DOSE | 2020-10-27 | 0000-00-00 | No | No | Current |
| 17856-5181-3 | 17856518103 | 50 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-5181-3) > 20 mL in 1 CUP, UNIT-DOSE | 2020-10-27 | 0000-00-00 | No | No | Current |