Sulfamethoxazole and Trimethoprim
- Product NDC
- 65162-272
- 11-digit product format
- 651620272
- Labeler code
- 65162
- Product ID
- 65162-272_fd58f01a-3607-4f18-97e3-f695bcb32ad5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA076899
- Marketing category
- ANDA
- Marketing start
- 2010-09-13
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sulfamethoxazole and Trimethoprim
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SULFAMETHOXAZOLE | 800 mg/1 |
| TRIMETHOPRIM | 160 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | AN164J8Y0X, JE42381TNV |
| Rxcui | 198334, 198335 |
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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 65162-272-01 | Sulfamethoxazole and Trimethoprim | 10 in 1 BOTTLE | TABLET | 10 | 12 | |
| 65162-272-10 | Sulfamethoxazole and Trimethoprim | 100 in 1 BOTTLE | TABLET | 100 | 12 | |
| 65162-272-24 | Sulfamethoxazole and Trimethoprim | 24 in 1 BOTTLE | TABLET | 24 | 12 | |
| 65162-272-25 | Sulfamethoxazole and Trimethoprim | 250 in 1 BOTTLE | TABLET | 250 | 12 | |
| 65162-272-50 | Sulfamethoxazole and Trimethoprim | 500 in 1 BOTTLE | TABLET | 500 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 65162-272-10 | EA - Each | 65162-272 | 82111e17-1bfc-49b0-85fc-f3f52ea8c543 | 1 | 2019-11-12 |
| 65162-272-50 | EA - Each | 65162-272 | 2568fc56-8213-4606-89f4-736982ed7ba3 | 1 | 2019-11-12 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| SULFAMETHOXAZOLE | ACTIVE INGREDIENT | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| TRIMETHOPRIM | ACTIVE INGREDIENT | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| SULFAMETHOXAZOLE | ACTIVE MOIETY | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| TRIMETHOPRIM | ACTIVE MOIETY | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [MAJOR PHARMACEUTICALS] | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | abe0d2d5-4879-4b4e-9b57-47ea83a17ba0 | 18 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | abe0d2d5-4879-4b4e-9b57-47ea83a17ba0 | 18 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | abe0d2d5-4879-4b4e-9b57-47ea83a17ba0 | 18 |
| 198334 | sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet | PSN | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 12 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 12 |
| 198334 | sulfamethoxazole 400 MG / trimethoprim 80 MG Oral Tablet | SCD | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 12 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 12 |
| 198334 | SMX 400 MG / TMP 80 MG Oral Tablet | SY | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 12 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | f0e73842-6002-43c2-97fc-0cadc1bf6346 | 12 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | b001e648-2710-3ada-e053-2995a90a52f1 | 5 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | b001e648-2710-3ada-e053-2995a90a52f1 | 5 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | b001e648-2710-3ada-e053-2995a90a52f1 | 5 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | f2b8e9d9-1274-22ca-e053-2a95a90a6f1a | 3 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | f2b8e9d9-1274-22ca-e053-2a95a90a6f1a | 3 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | f2b8e9d9-1274-22ca-e053-2a95a90a6f1a | 3 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | 0b261114-77e7-ff08-e063-6394a90a4e03 | 2 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | 0b261114-77e7-ff08-e063-6394a90a4e03 | 2 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | 0b261114-77e7-ff08-e063-6394a90a4e03 | 2 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | b85a58a7-74d6-4629-8027-0cdcbb5c815a | 1 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | 0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d | 1 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | PSN | 07da67b1-b50c-4471-8cde-8a119eb8c935 | 1 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | b85a58a7-74d6-4629-8027-0cdcbb5c815a | 1 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | 0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d | 1 |
| 198335 | sulfamethoxazole 800 MG / trimethoprim 160 MG Oral Tablet | SCD | 07da67b1-b50c-4471-8cde-8a119eb8c935 | 1 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | b85a58a7-74d6-4629-8027-0cdcbb5c815a | 1 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | 0aaf1dbe-b69d-43bd-a4ab-69cb27ab417d | 1 |
| 198335 | SMX 800 MG / TMP 160 MG Oral Tablet | SY | 07da67b1-b50c-4471-8cde-8a119eb8c935 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 65162-272-01 | 65162027201 | 10 TABLET in 1 BOTTLE (65162-272-01) | 10 tablet | 2010-09-13 | 0000-00-00 | No | No | Current |
| 65162-272-10 | 65162027210 | 100 TABLET in 1 BOTTLE (65162-272-10) | 100 tablet | 2010-09-13 | 0000-00-00 | No | No | Current |
| 65162-272-24 | 65162027224 | 24 TABLET in 1 BOTTLE (65162-272-24) | 24 tablet | 2010-09-13 | 0000-00-00 | No | No | Current |
| 65162-272-25 | 65162027225 | 250 TABLET in 1 BOTTLE (65162-272-25) | 250 tablet | 2010-09-13 | 0000-00-00 | No | No | Current |
| 65162-272-50 | 65162027250 | 500 TABLET in 1 BOTTLE (65162-272-50) | 500 tablet | 2010-09-13 | 0000-00-00 | No | No | Current |