Prescription drug · ANDA
Sulfamethoxazole and Trimethoprim NDC 71335-0762
Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-0762-0 | 71335076200 | 21 TABLET in 1 BOTTLE (71335-0762-0)Marketed from Jul 24, 2020 | |
| 71335-0762-1 | 71335076201 | 20 TABLET in 1 BOTTLE (71335-0762-1)Marketed from Jun 19, 2018 | |
| 71335-0762-2 | 71335076202 | 14 TABLET in 1 BOTTLE (71335-0762-2)Marketed from Apr 5, 2018 | |
| 71335-0762-3 | 71335076203 | 10 TABLET in 1 BOTTLE (71335-0762-3)Marketed from Mar 29, 2018 | |
| 71335-0762-4 | 71335076204 | 28 TABLET in 1 BOTTLE (71335-0762-4)Marketed from Mar 26, 2018 | |
| 71335-0762-5 | 71335076205 | 40 TABLET in 1 BOTTLE (71335-0762-5)Marketed from Apr 24, 2018 | |
| 71335-0762-6 | 71335076206 | 6 TABLET in 1 BOTTLE (71335-0762-6)Marketed from Nov 4, 2019 | |
| 71335-0762-7 | 71335076207 | 60 TABLET in 1 BOTTLE (71335-0762-7)Marketed from Nov 10, 2020 | |
| 71335-0762-8 | 71335076208 | 30 TABLET in 1 BOTTLE (71335-0762-8)Marketed from Jun 18, 2018 | |
| 71335-0762-9 | 71335076209 | 13 TABLET in 1 BOTTLE (71335-0762-9)Marketed from Oct 7, 2024 |
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 — 800 mg/1Trimethoprim — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- 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 71335-0762_4b2d2aad-d2b6-467d-a18c-9b346ae04ee5SPL ID 4b2d2aad-d2b6-467d-a18c-9b346ae04ee5SPL set ID 27bebe39-c069-4a9d-99d1-c7cf44ac2f41RxCUI 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
N471335076200followed by a unit qualifier and the quantityPackage 71335-0762-00. 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.
About NDC 71335-0762
- What is NDC 71335-0762?
- 71335-0762 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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 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 |
|---|---|---|---|---|
| Sulfameth/Trimeth-DS | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Direct_Rx | 61919-645 |
| 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 | QPharma, Inc. | 42708-053 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-2198 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-2199 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-2200 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-2201 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-2479 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-5679 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-5680 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | A-S Medication Solutions | 50090-5682 |
| 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 | A-S Medication Solutions | 50090-7399 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | AvPAK | 50268-728 |
| 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 | Cardinal Health 107, LLC | 55154-2580 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Quality Care Products LLC | 55700-611 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-232 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-233 |
| Sulfamethoxazole and Trimethoprim | Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 | TabletOral | American Health Packaging | 60687-614 |
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