Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim NDC 82982-044
Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Tablet · Oral · Pharmasource Meds, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82982-044-14 | 82982004414 | 14 TABLET in 1 BOTTLE (82982-044-14)Marketed from Feb 28, 2023 | |
| 82982-044-20 | 82982004420 | 20 TABLET in 1 BOTTLE (82982-044-20)Marketed from Feb 28, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Sulfamethoxazole and Trimethoprim
- Generic name (nonproprietary)
- sulfamethoxazole and trimethoprim
- Active ingredients
- Sulfamethoxazole — 800 mg/1Trimethoprim — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Pharmasource Meds, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090624
- Marketing start
- Marketing end
- Other FDA classes
- Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)Dihydrofolate Reductase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)Sulfonamides (Chemical structure)
- Identifiers
- Product ID 82982-044_198ccc85-82fd-0a2b-e063-6394a90a249fSPL ID 198ccc85-82fd-0a2b-e063-6394a90a249fSPL set ID f564a029-4b20-301a-e053-2995a90adcc0RxCUI 198335UNII JE42381TNV, AN164J8Y0XUPC 0382982044204, 0382982044143
- Pharmacologic class
- Dihydrofolate Reductase Inhibitor Antibacterial; Sulfonamide Antimicrobial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N482982004414followed by a unit qualifier and the quantityPackage 82982-0044-14. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim tablets and other antibacterial drugs, sulfamethoxazole and trimethoprim tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to susceptible s…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090624
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Proficient Rx LP | 63187-695 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 66267-816 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Coupler LLC | 67046-0295 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Sportpharm LLC | 85766-015 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7393 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-018 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7399 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0863 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-064 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | American Health Packaging | 60687-614 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4710 |
| Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim | Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0003 |
| Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0002 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-078 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-188 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8121 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | VERITYRX, LLC | 83939-0023 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-419 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-420 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-2201 |
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