Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim NDC 63187-008
Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-008-06 | 63187000806 | 6 TABLET in 1 BOTTLE (63187-008-06)Marketed from Nov 1, 2018 | |
| 63187-008-10 | 63187000810 | 10 TABLET in 1 BOTTLE (63187-008-10)Marketed from Nov 1, 2018 | |
| 63187-008-14 | 63187000814 | 14 TABLET in 1 BOTTLE (63187-008-14)Marketed from Nov 1, 2018 | |
| 63187-008-20 | 63187000820 | 20 TABLET in 1 BOTTLE (63187-008-20)Marketed from Nov 1, 2018 | |
| 63187-008-28 | 63187000828 | 28 TABLET in 1 BOTTLE (63187-008-28)Marketed from Nov 1, 2018 | |
| 63187-008-40 | 63187000840 | 40 TABLET in 1 BOTTLE (63187-008-40)Marketed from Nov 1, 2018 |
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
- Proficient Rx LPNDC labeler code 63187
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076817
- 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 63187-008_2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5caSPL ID 2dd0e8d4-6ac3-433f-a41f-1e55d2b3f5caSPL set ID c407381f-3d8e-4fdf-9132-cd3968099296RxCUI 198335UNII JE42381TNV, AN164J8Y0XUPC 0363187008109
- 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
N463187000806followed by a unit qualifier and the quantityPackage 63187-0008-06. 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 the empiric selection of therapy. Urinary Tract Infections For the treatment of urinary tract infections due to susceptib…
Excerpt only. Read the full label for complete information.
About NDC 63187-008
- What is NDC 63187-008?
- 63187-008 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 6 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sulfamethoxazole and Trimethoprim.
- What is the active ingredient?
- Sulfamethoxazole, Trimethoprim.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 63187. 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?
- 89 other product NDCs are listed under this name. See all Sulfamethoxazole and Trimethoprim 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 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 | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-078 | 87441-0078-01 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Coupler LLC | 67046-0295 | 67046-0295-03 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-2580 | 55154-2580-00 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-092 | 82868-0092-28 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | American Health Packaging | 60687-442 | 60687-0442-75 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | PAI Holdings, LLC dba PAI Pharma | 0121-0853 | 00121-0853-20 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL | SuspensionOral | Preferred Pharmaceuticals Inc. | 68788-8607 | 68788-8607-04 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-188 | 51655-0188-2051655-0188-5351655-0188-84+1 more |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Pharmasource Meds, LLC | 82982-044 | 82982-0044-1482982-0044-20 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-307 | 51655-0307-2051655-0307-2951655-0307-53+2 more |
Other NDCs under ANDA 076817
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 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | Vista Pharmaceuticals, Inc. | 61971-115 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Vista Pharmaceuticals, Inc. | 61971-120 |