Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim NDC 60687-442
Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL · Suspension · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-442-75 | 60687044275 | 4 TRAY in 1 CASE (60687-442-75) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-442-53) / 20 mL in 1 CUP, UNIT-DOSE (60687-442-24)Marketed from Nov 7, 2024 |
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 — 200 mg/5mLTrimethoprim — 40 mg/5mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091348
- 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 60687-442_3546bee9-e4fa-333e-e063-6394a90a4200SPL ID 3546bee9-e4fa-333e-e063-6394a90a4200SPL set ID f14b8d07-e73b-4ceb-bd6a-578c961b7c09RxCUI 313134UNII 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
N460687044275followed by a unit qualifier and the quantityPackage 60687-0442-75. 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 oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091348
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 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | ATLANTIC BIOLOGICALS CORP. | 17856-0496 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | A-S Medication Solutions | 50090-0525 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | Aurobindo Pharma Limited | 65862-496 |