Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim NDC 17856-0496
Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL · Suspension · Oral · ATLANTIC BIOLOGICALS CORP.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0496-4 | 17856049604 | 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-4) / 5 mL in 1 CUP, UNIT-DOSE (17856-0496-1)Marketed from Apr 12, 2024 | |
| 17856-0496-5 | 17856049605 | 50 CUP, UNIT-DOSE in 1 BOX (17856-0496-5) / 20 mL in 1 CUP, UNIT-DOSE (17856-0496-3)Marketed from Apr 12, 2024 | |
| 17856-0496-6 | 17856049606 | 72 CUP, UNIT-DOSE in 1 BOX (17856-0496-6) / 10 mL in 1 CUP, UNIT-DOSE (17856-0496-2)Marketed from Apr 12, 2024 | |
| 17856-0496-7 | 17856049607 | 48 SYRINGE in 1 CASE (17856-0496-7) / 5 mL in 1 SYRINGEMarketed from Aug 5, 2026 | |
| 17856-0496-8 | 17856049608 | 48 SYRINGE in 1 CASE (17856-0496-8) / 10 mL in 1 SYRINGEMarketed from Aug 5, 2026 | |
| 17856-0496-9 | 17856049609 | 48 CUP, UNIT-DOSE in 1 CASE (17856-0496-9) / 20 mL in 1 CUP, UNIT-DOSEMarketed from Aug 25, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- ATLANTIC BIOLOGICALS CORP.
- 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 17856-0496_59e36b9b-746f-dd25-e063-6394a90aded8SPL ID 59e36b9b-746f-dd25-e063-6394a90aded8SPL set ID acc3df02-1e99-46e6-8a31-9b26261c6daaRxCUI 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
N417856049604followed by a unit qualifier and the quantityPackage 17856-0496-04. 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, USP and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension, USP 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 infec…
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 | American Health Packaging | 60687-442 |
| 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 |