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NDC 70069-0361-10 Sulfamethoxazole and Trimethoprim 80; 16 mg/mL; mg/mL Details
Sulfamethoxazole and Trimethoprim 80; 16 mg/mL; mg/mL
Sulfamethoxazole and Trimethoprim is a INTRAVENOUS INJECTION, SOLUTION, CONCENTRATE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Somerset Therapeutics, LLC. The primary component is SULFAMETHOXAZOLE; TRIMETHOPRIM.
MedlinePlus Drug Summary
Co-trimoxazole injection is used to treat certain infections that are caused by bacteria such as infection of the intestine, lungs (pneumonia), and urinary tract. Co-trimoxazole should not be used in children younger than 2 months of age. Co-trimoxazole injection is in a class of medications called sulfonamides. It works by killing bacteria. Antibiotics such as co-trimoxazole injection will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Related Packages: 70069-0361-10Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Co-trimoxazole Injection
Product Information
| NDC | 70069-0361 |
|---|---|
| Product ID | 70069-361_55953381-5afa-4a77-8ac7-e07b5c35e3dc |
| Associated GPIs | 16990002302010 |
| GCN Sequence Number | 009393 |
| GCN Sequence Number Description | sulfamethoxazole/trimethoprim VIAL 80-16MG/ML INTRAVEN |
| HIC3 | W2A |
| HIC3 Description | ABSORBABLE SULFONAMIDE ANTIBACTERIAL AGENTS |
| GCN | 90139 |
| HICL Sequence Number | 004071 |
| HICL Sequence Number Description | SULFAMETHOXAZOLE/TRIMETHOPRIM |
| Brand/Generic | Generic |
| Proprietary Name | Sulfamethoxazole and Trimethoprim |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Sulfamethoxazole and Trimethoprim |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION, CONCENTRATE |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 80; 16 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | SULFAMETHOXAZOLE; TRIMETHOPRIM |
| Labeler Name | Somerset Therapeutics, LLC |
| Pharmaceutical Class | 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], Su |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212231 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70069-0361-10 (70069036110)
| NDC Package Code | 70069-361-10 |
|---|---|
| Billing NDC | 70069036110 |
| Package | 10 VIAL in 1 CARTON (70069-361-10) / 5 mL in 1 VIAL (70069-361-01) |
| Marketing Start Date | 2019-08-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |