Prescription drug · NDA
Bactrim DS (Sulfamethoxazole and trimethoprim) NDC 49708-146
Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 · Tablet · Oral · Sun Pharmaceutical Industries, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49708-146-01 | 49708014601 | 100 TABLET in 1 BOTTLE, PLASTIC (49708-146-01)Marketed from Nov 1, 2004 |
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)
- Bactrim DS
- Generic name (nonproprietary)
- sulfamethoxazole and trimethoprim
- Active ingredients
- Sulfamethoxazole — 800 mg/1Trimethoprim — 160 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, IncNDC labeler code 49708
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017377
- 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 49708-146_2a76a544-1f84-4b42-e063-6394a90a08d5SPL ID 2a76a544-1f84-4b42-e063-6394a90a08d5SPL set ID f59d0c04-9c66-4d53-a0e1-cb55570deb62RxCUI 198334, 198335, 208416, 849580UNII JE42381TNV, AN164J8Y0XUPC 0349708146017, 0349708145010
- 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
N449708014601followed by a unit qualifier and the quantityPackage 49708-0146-01. 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 To reduce the development of drug-resistant bacteria and maintain the effectiveness of BACTRIM (sulfamethoxazole and trimethoprim) tablets and other antibacterial drugs, BACTRIM (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 …
Excerpt only. Read the full label for complete information.
About NDC 49708-146
- What is NDC 49708-146?
- 49708-146 is the product NDC for Bactrim DS, Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1 tablet, listed with the FDA by Sun Pharmaceutical Industries, Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bactrim DS (Sulfamethoxazole and Trimethoprim).
- What is the active ingredient?
- Sulfamethoxazole, Trimethoprim.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc, NDC labeler code 49708. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bactrim DS?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 017377
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 |
|---|---|---|---|---|
| Bactrimsulfamethoxazole and trimethoprim | Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc | 49708-145 |