Sulfamethoxazole and Trimethoprim NDC 53746-271

NDC codes

FDA NDC Directory

Product NDC (as listed)53746-271Labeler and product segments. Claims need a package NDC.

Product NDC at billing width53746-0271Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
53746-271-01	53746027101	100 TABLET in 1 BOTTLE (53746-271-01)Marketed from Feb 25, 2010
53746-271-05	53746027105	500 TABLET in 1 BOTTLE (53746-271-05)Marketed from Feb 25, 2010
53746-271-10	53746027110	1000 TABLET in 1 BOTTLE (53746-271-10)Marketed from Feb 25, 2010
53746-271-50	53746027150	50 TABLET in 1 BOTTLE (53746-271-50)Marketed from Feb 25, 2010

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 — 400 mg/1Trimethoprim — 80 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Amneal Pharmaceuticals of New York LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076899
Marketing start: Feb 25, 2010
Listing expires: Dec 31, 2026
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 53746-271_bc5fe496-071b-4c25-95da-14c6c561e79eSPL ID bc5fe496-071b-4c25-95da-14c6c561e79eSPL set ID 3233c54d-484d-4550-b172-db8af47d1b7fRxCUI 198334, 198335UNII JE42381TNV, AN164J8Y0XUPC 0353746271013, 0353746272010
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

N453746027101 followed by a unit qualifier and the quantity

Package 53746-0271-01. 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 Feb 26, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 076899

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 076899
Product	Strength	Form · route	Labeler	Product NDC
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim	Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0001
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	Proficient Rx LP	63187-782
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 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	50090-6904
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	50090-6901
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	AvKARE	42291-759
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	Amneal Pharmaceuticals LLC	65162-272
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	A-S Medication Solutions	50090-7008
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 800 mg/1; Trimethoprim 160 mg/1	TabletOral	Cardinal Health 107, LLC	55154-7895