What is NDC 65162-271?

65162-271 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

What is the active ingredient?

Sulfamethoxazole, Trimethoprim.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Sulfamethoxazole and Trimethoprim NDC 65162-271

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-271Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0271Add 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
65162-271-05	65162027105	50 TABLET in 1 BOTTLE (65162-271-05)Marketed from Feb 25, 2010
65162-271-10	65162027110	100 TABLET in 1 BOTTLE (65162-271-10)Marketed from Feb 25, 2010
65162-271-11	65162027111	1000 TABLET in 1 BOTTLE (65162-271-11)Marketed from Feb 25, 2010
65162-271-50	65162027150	500 TABLET in 1 BOTTLE (65162-271-50)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 LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076899
Marketing start: Feb 25, 2010
Listing expires: Dec 31, 2027
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 65162-271_fd58f01a-3607-4f18-97e3-f695bcb32ad5SPL ID fd58f01a-3607-4f18-97e3-f695bcb32ad5SPL set ID f0e73842-6002-43c2-97fc-0cadc1bf6346RxCUI 198334, 198335UNII JE42381TNV, AN164J8Y0XUPC 0365168211102, 0365162272109
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

N465162027105 followed by a unit qualifier and the quantity

Package 65162-0271-05. 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 Apr 2, 2026.

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)

About NDC 65162-271

What is NDC 65162-271?: 65162-271 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Sulfamethoxazole and Trimethoprim NDCs
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

All 90 Sulfamethoxazole and Trimethoprim NDCs

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	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 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
Sulfamethoxazole and Trimethoprim DSsulfamethoxazole and trimethoprim	Trimethoprim 160 mg/1; Sulfamethoxazole 800 mg/1	TabletOral	Advanced Rx Pharmacy of Tennessee, LLC	80425-0001