Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim NDC 69043-010
Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 · Tablet · Oral · Cronus Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69043-010-01 | 69043001001 | 100 TABLET in 1 BOTTLE (69043-010-01)Marketed from Feb 16, 2010 | |
| 69043-010-05 | 69043001005 | 500 TABLET in 1 BOTTLE (69043-010-05)Marketed from Feb 16, 2010 |
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 — 400 mg/1Trimethoprim — 80 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cronus Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090624
- Marketing start
- Listing expires
- 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 69043-010_17de019d-ffdf-436a-bcae-2941f844123aSPL ID 17de019d-ffdf-436a-bcae-2941f844123aSPL set ID 1b5de94f-973a-4b5a-91d7-45e05be78650RxCUI 198334, 198335UNII JE42381TNV, AN164J8Y0X
- 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
N469043001001followed by a unit qualifier and the quantityPackage 69043-0010-01. 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 | Pharmasource Meds, LLC | 82982-044 |
| 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 |
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