Sulfamethoxazole and Trimethoprim
- Product NDC
- 66267-816
- 11-digit product format
- 662670816
- Labeler code
- 66267
- Product ID
- 66267-816_1fa78994-2830-fe39-e063-6394a90af951
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals, Inc.
- Application
- ANDA090624
- Marketing category
- ANDA
- Marketing start
- 2010-02-16
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sulfamethoxazole and Trimethoprim
- Listing expiration
- 2026-12-31
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 |
|---|
| 66267-816-02 | Sulfamethoxazole and Trimethoprim | 2 in 1 BOTTLE | TABLET | 2 | | 4 |
| 66267-816-04 | Sulfamethoxazole and Trimethoprim | 4 in 1 BOTTLE | TABLET | 4 | | 4 |
| 66267-816-06 | Sulfamethoxazole and Trimethoprim | 6 in 1 BOTTLE | TABLET | 6 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66267-816 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NUCARE PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 3 package rows | 20240815_46dc8f62-e700-50e3-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 66267-816-02 | 66267081602 | 2 TABLET in 1 BOTTLE (66267-816-02) | 2 tablet | 2017-01-24 | 0000-00-00 | No | No | Current |
| 66267-816-04 | 66267081604 | 4 TABLET in 1 BOTTLE (66267-816-04) | 4 tablet | 2017-01-24 | 0000-00-00 | No | No | Current |
| 66267-816-06 | 66267081606 | 6 TABLET in 1 BOTTLE (66267-816-06) | 6 tablet | 2017-01-24 | 0000-00-00 | No | No | Current |