NDC codes

FDA NDC Directory
Product NDC (as listed)50090-0525Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-0525Add 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 NDC11-digit (billing)PackageCopy
50090-0525-050090052500473 mL in 1 BOTTLE (50090-0525-0)Marketed from Jun 29, 2016

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091348
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 50090-0525_6b5fe102-d381-4461-aaa6-61a1f6679d39SPL ID 6b5fe102-d381-4461-aaa6-61a1f6679d39SPL set ID 69af86b4-9c9f-4a70-b448-97b36698f3cdRxCUI 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

N450090052500 followed by a unit qualifier and the quantity

Package 50090-0525-00. 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 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)

Other NDCs under ANDA 091348

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

FDA NDC Directory listings under ANDA 091348
ProductStrengthForm · routeLabelerProduct NDC
Sulfamethoxazole and TrimethoprimSulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mLSuspensionOralATLANTIC BIOLOGICALS CORP.17856-0496
Sulfamethoxazole and TrimethoprimSulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mLSuspensionOralAmerican Health Packaging60687-442
Sulfamethoxazole and TrimethoprimSulfamethoxazole 200 mg/5mL; Trimethoprim 40 mg/5mLSuspensionOralAurobindo Pharma Limited65862-496

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