Sulfamethoxazole and Trimethoprim
- Product NDC
- 0703-9514
- 11-digit product format
- 007039514
- Labeler code
- 0703
- Product ID
- 0703-9514_03a1a8ab-99e0-4f3a-bcd8-79a902eaf27e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sulfamethoxazole and Trimethoprim
- Dosage form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- ANDA073303
- Marketing category
- ANDA
- Marketing start
- 2024-07-11
- Substance
- SULFAMETHOXAZOLE; TRIMETHOPRIM
- Active strength
- 80; 16 mg/mL; mg/mL
- 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 | 80 mg/mL |
| TRIMETHOPRIM | 16 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AN164J8Y0X, JE42381TNV |
| Rxcui | 313137 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0703-9514-01 | Sulfamethoxazole and Trimethoprim | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 18 |
| 0703-9514-03 | Sulfamethoxazole and Trimethoprim | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 18 |
| 0703-9514-81 | Sulfamethoxazole and Trimethoprim | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 14 |
| 0703-9514-83 | Sulfamethoxazole and Trimethoprim | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 14 |
| 0703-9514-91 | Sulfamethoxazole and Trimethoprim | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | | 6 |
| 0703-9514-93 | Sulfamethoxazole and Trimethoprim | 10 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 10 | | 6 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SULFAMETHOXAZOLE | ACTIVE INGREDIENT | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| TRIMETHOPRIM | ACTIVE INGREDIENT | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| SULFAMETHOXAZOLE | ACTIVE MOIETY | JE42381TNV | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| TRIMETHOPRIM | ACTIVE MOIETY | AN164J8Y0X | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| BENZYL ALCOHOL | INACTIVE INGREDIENT | LKG8494WBH | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| DIETHANOLAMINE | INACTIVE INGREDIENT | AZE05TDV2V | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| SODIUM METABISULFITE | INACTIVE INGREDIENT | 4VON5FNS3C | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 9 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0703-9514 | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 17 | Current NDC, Legacy NDC, 2 package rows | 20250510_b89b5502-ce87-45a6-a43c-9891da3cfca4.zip |
| 0703-9514 | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20241004_bf7a0845-de4f-46be-841a-0faf47f8b530.zip |
| 0703-9514 | SULFAMETHOXAZOLE AND TRIMETHOPRIM INJECTION, SOLUTION, CONCENTRATE [TEVA PARENTERAL MEDICINES, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20230629_640f5b0c-748d-4a68-a1de-59cc3e00ed49.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 |
|---|
| 0703-9514-01 | 00703951401 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 0703-9514-03 | 00703951403 | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-03) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-01) | | 1991-11-01 | 0000-00-00 | No | No | Current |
| 0703-9514-81 | 00703951481 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 0703-9514-83 | 00703951483 | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-83) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-81) | | 2024-07-11 | | No | No | Current |
| 0703-9514-91 | 00703951491 | 10 mL in 1 VIAL, MULTI-DOSE | 10 ml | | | | | Historical |
| 0703-9514-93 | 00703951493 | 10 VIAL, MULTI-DOSE in 1 CARTON (0703-9514-93) / 10 mL in 1 VIAL, MULTI-DOSE (0703-9514-91) | | 1991-11-01 | 0000-00-00 | No | No | Current |