What is NDC 0121-0853?

0121-0853 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Sulfamethoxazole, Trimethoprim.

PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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 0121-0853

NDC codes

FDA NDC Directory

Product NDC (as listed)0121-0853Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00121-0853Add 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	Copy
0121-0853-20	00121085320	10 CUP, UNIT-DOSE in 1 TRAY (0121-0853-20) / 20 mL in 1 CUP, UNIT-DOSEMarketed from Aug 5, 2024

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 200 mg/5mLTrimethoprim — 40 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: PAI Holdings, LLC dba PAI PharmaNDC labeler code 0121
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 018615
Marketing start: Aug 5, 2024
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 0121-0853_533790e4-bcfb-447d-9665-0457f3c10c2aSPL ID 533790e4-bcfb-447d-9665-0457f3c10c2aSPL set ID 777da85a-a776-4681-976d-326ec421cfc9RxCUI 313134UNII 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

N400121085320 followed by a unit qualifier and the quantity

Package 00121-0853-20. 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 Aug 1, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of sulfamethoxazole and trimethoprim oral suspension and other antibacterial drugs, sulfamethoxazole and trimethoprim oral suspension 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0121-0853

What is NDC 0121-0853?: 0121-0853 is the product NDC for Sulfamethoxazole and Trimethoprim, Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL suspension, listed with the FDA by PAI Holdings, LLC dba PAI Pharma. It has 1 package NDC, 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?: PAI Holdings, LLC dba PAI Pharma, NDC labeler code 0121. 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	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
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 400 mg/1; Trimethoprim 80 mg/1	TabletOral	REMEDYREPACK INC.	70518-3454	70518-3454-0370518-3454-04

All 90 Sulfamethoxazole and Trimethoprim NDCs

Other NDCs under NDA 018615

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

FDA NDC Directory listings under NDA 018615
Product	Strength	Form · route	Labeler	Product NDC
Sulfatrimsulfamethoxazole and trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	A-S Medication Solutions	50090-7836
Sulfatrimsulfamethoxazole and trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	Preferred Pharmaceuticals, Inc.	68788-7345
Sulfatrimsulfamethoxazole and trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	PAI Holdings, LLC dba PAI Pharma	0121-0854