Sulfamethoxazole and Trimethoprim NDC 81033-012

NDC codes

FDA NDC Directory

Product NDC (as listed)81033-012Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81033-0012Add 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
81033-012-40	81033001240	40 CUP, UNIT-DOSE in 1 CARTON (81033-012-40) / 20 mL in 1 CUP, UNIT-DOSE (81033-012-20)Marketed from Apr 4, 2025

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 — 200 mg/5mLTrimethoprim — 40 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Kesin Pharma
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077612
Marketing start: Jul 5, 2022
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 81033-012_35063fad-e644-2b68-e063-6394a90aedc8SPL ID 35063fad-e644-2b68-e063-6394a90aedc8SPL set ID 31f9e720-3869-061f-e063-6294a90a43b4RxCUI 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

N481033001240 followed by a unit qualifier and the quantity

Package 81033-0012-40. 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 May 13, 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 and other antibacterial drugs, sulfamethoxazole and trimethoprim 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 strains of the fol…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 077612

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

FDA NDC Directory listings under ANDA 077612
Product	Strength	Form · route	Labeler	Product NDC
Sulfamethoxazole and Trimethoprim	Sulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mL	SuspensionOral	Prasco Laboratories	66993-727