Sulfamethoxazole and Trimethoprim
- Product NDC
- 0615-8121
- 11-digit product format
- 006158121
- Labeler code
- 0615
- Product ID
- 0615-8121_18da7fe1-4328-4868-9e5f-65e7d3dde75d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- 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 |
|---|
| 0615-8121-10 | Sulfamethoxazole and Trimethoprim | 10 in 1 BLISTER PACK | TABLET | 10 | | 16 |
| 0615-8121-14 | Sulfamethoxazole and Trimethoprim | 14 in 1 BLISTER PACK | TABLET | 14 | | 16 |
| 0615-8121-20 | Sulfamethoxazole and Trimethoprim | 20 in 1 BLISTER PACK | TABLET | 20 | | 16 |
| 0615-8121-39 | Sulfamethoxazole and Trimethoprim | 30 in 1 BLISTER PACK | TABLET | 30 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8121 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 16 | Current NDC, Legacy NDC, 4 package rows | 20240206_c2307cc2-43ee-4319-ad58-d1d28a95e5aa.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 |
|---|
| 0615-8121-10 | 00615812110 | 10 TABLET in 1 BLISTER PACK (0615-8121-10) | 10 tablet | 2010-02-16 | 0000-00-00 | No | No | Current |
| 0615-8121-14 | 00615812114 | 14 TABLET in 1 BLISTER PACK (0615-8121-14) | 14 tablet | 2010-02-16 | 0000-00-00 | No | No | Current |
| 0615-8121-20 | 00615812120 | 20 TABLET in 1 BLISTER PACK (0615-8121-20) | 20 tablet | 2024-01-30 | | No | No | Current |
| 0615-8121-39 | 00615812139 | 30 TABLET in 1 BLISTER PACK (0615-8121-39) | 30 tablet | 2024-01-30 | | No | No | Current |