Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim DS (Sulfamethoxazole and trimethoprim) NDC 80425-0001
Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0001-1 | 80425000101 | 14 TABLET in 1 BOTTLE (80425-0001-1)Marketed from Sep 13, 2010 |
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 DSSuffix: DS
- Generic name (nonproprietary)
- sulfamethoxazole and trimethoprim
- Active ingredients
- Trimethoprim — 160 mg/1Sulfamethoxazole — 800 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076899
- 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 80425-0001_2a96f37d-03f7-678c-e063-6394a90ae0c6SPL ID 2a96f37d-03f7-678c-e063-6394a90ae0c6SPL set ID b001e648-2710-3ada-e053-2995a90a52f1RxCUI 198335UNII AN164J8Y0X, JE42381TNV
- 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
N480425000101followed by a unit qualifier and the quantityPackage 80425-0001-01. 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 Section 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 …
Excerpt only. Read the full label for complete information.
About NDC 80425-0001
- What is NDC 80425-0001?
- 80425-0001 is the product NDC for Sulfamethoxazole and Trimethoprim DS, Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sulfamethoxazole and Trimethoprim DS (Sulfamethoxazole and Trimethoprim).
- What is the active ingredient?
- Trimethoprim, Sulfamethoxazole.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sulfamethoxazole and Trimethoprim DS?
- 2 other product NDCs are listed under this name. See all Sulfamethoxazole and Trimethoprim DS NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sulfamethoxazole and Trimethoprim DS products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim | Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0003 | 80425-0003-0180425-0003-0280425-0003-03+1 more |
| Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0002 | 80425-0002-01 |
Other NDCs under ANDA 076899
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 | 63187-782 |
| Sulfamethox-TMP DSsulfamethoxazole, trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | PharmPak, Inc. | 54348-625 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Major Pharmaceuticals | 0904-2725 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-4850 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-4847 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-4848 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1765 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-271 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-307 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Amneal Pharmaceuticals of New York LLC | 53746-272 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6901 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6902 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-6904 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | AvKARE | 42291-758 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-271 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | AvKARE | 42291-759 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-272 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7895 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-7008 |