Sulfamethoxazole and Trimethoprim
- Product NDC
- 67046-0295
- 11-digit product format
- 670460295
- Labeler code
- 67046
- Product ID
- 67046-0295_518cb856-c9c4-09f7-e063-6294a90a47d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA090624
- Marketing category
- ANDA
- Marketing start
- 2026-05-11
- 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 table| Ingredient | Strength |
|---|
| SULFAMETHOXAZOLE | 800 mg/1 |
| TRIMETHOPRIM | 160 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JE42381TNV, AN164J8Y0X |
| Rxcui | 198335 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67046-0295-3 | Sulfamethoxazole and Trimethoprim | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-0295-3 | 67046029503 | 30 TABLET in 1 BLISTER PACK (67046-0295-3) | 30 tablet | 2026-05-11 | No | No | Historical |