Sulfamethoxazole and Trimethoprim
- Product NDC
- 10544-053
- 11-digit product format
- 105440053
- Labeler code
- 10544
- Product ID
- 10544-053_112f3db2-aa31-4559-e054-00144ff8d46c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Blenheim Pharmacal, Inc.
- Application
- ANDA090624
- Marketing category
- ANDA
- Marketing start
- 2011-09-09
- Marketing end
- 0000-00-00
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 800 mg/1; mg/1
- Pharmacologic classes
- Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10544-053-06 | Sulfamethoxazole and Trimethoprim | 6 in 1 BOTTLE | TABLET | 6 | | 1 |
| 10544-053-14 | Sulfamethoxazole and Trimethoprim | 14 in 1 BOTTLE | TABLET | 14 | | 1 |
| 10544-053-20 | Sulfamethoxazole and Trimethoprim | 20 in 1 BOTTLE | TABLET | 20 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SULFAMETHOXAZOLE | ACTIVE INGREDIENT | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TRIMETHOPRIM | ACTIVE INGREDIENT | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SULFAMETHOXAZOLE | ACTIVE MOIETY | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| TRIMETHOPRIM | ACTIVE MOIETY | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| DOCUSATE SODIUM | INACTIVE INGREDIENT | F05Q2T2JA0 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10544-053 | SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [BLENHEIM PHARMACAL, INC.] | 1 | Legacy NDC, 3 package rows | 20150313_112f3db2-aa30-4559-e054-00144ff8d46c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Status |
|---|
| 10544-053-06 | 10544005306 | 6 in 1 BOTTLE | Historical |
| 10544-053-14 | 10544005314 | 14 in 1 BOTTLE | Historical |
| 10544-053-20 | 10544005320 | 20 in 1 BOTTLE | Historical |