Sulfamethoxazole and Trimethoprim
- Product NDC
- 80425-0002
- 11-digit product format
- 804250002
- Labeler code
- 80425
- Product ID
- 80425-0002_2a9804bb-d5c4-5a9a-e063-6294a90a973d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLC
- 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
- Brand name suffix
- DS
- 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 |
|---|
| 80425-0002-1 | Sulfamethoxazole and TrimethoprimDS | 14 in 1 BOTTLE | TABLET | 14 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 80425-0002 | SULFAMETHOXAZOLE AND TRIMETHOPRIM DS (SULFAMETHOXAZOLE AND TRIMETHOPRIM) TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250101_b000150f-3be6-2e6c-e053-2995a90a67d5.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 |
|---|
| 80425-0002-1 | 80425000201 | 14 TABLET in 1 BOTTLE (80425-0002-1) | 14 tablet | 2010-02-16 | 0000-00-00 | No | No | Current |