SULFAMETH/TRIMETH-DS is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Sulfamethoxazole; Trimethoprim.
| Product ID | 61919-645_7cc4029e-5f4c-880a-e053-2991aa0a3264 |
| NDC | 61919-645 |
| Product Type | Human Prescription Drug |
| Proprietary Name | SULFAMETH/TRIMETH-DS |
| Generic Name | Sulfameth/trimeth-ds |
| Dosage Form | Tablet |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-12-11 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA090624 |
| Labeler Name | DIRECT RX |
| Substance Name | SULFAMETHOXAZOLE; TRIMETHOPRIM |
| Active Ingredient Strength | 800 mg/1; mg/1 |
| Pharm 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 | N |
| Listing Certified Through | 2020-12-31 |
| Marketing Start Date | 2018-12-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2018-12-11 |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-04-22 |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-17 |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-08-13 |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2019-08-13 |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-07-02 |
| Marketing Category | ANDA |
| Application Number | ANDA090624 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 2019-08-06 |
| Ingredient | Strength |
|---|---|
| SULFAMETHOXAZOLE | 800 mg/1 |
| SPL SET ID: | 7cc4029e-5f4b-880a-e053-2991aa0a3264 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |