Dextromethorphan HBr. and Guaifenesin NDC 57237-312

NDC codes

FDA NDC Directory

Product NDC (as listed)57237-312Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57237-0312Add 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
57237-312-51	57237031251	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-312-51) / 5 mL in 1 CUP, UNIT-DOSE (57237-312-05)Marketed from Jun 12, 2023

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): Dextromethorphan HBr. and Guaifenesin
Generic name (nonproprietary): dextromethorphan hbr. and guaifenesin
Active ingredients: Dextromethorphan hydrobromide — 10 mg/5mLGuaifenesin — 100 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Rising Pharma Holdings, Inc.
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M012.85
Marketing start: Jun 12, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Decreased Respiratory Secretion Viscosity (Physiologic effect)Increased Respiratory Secretions (Physiologic effect)Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 57237-312_6c9e7e2a-5fb7-4e1b-813e-d0ab33a43502SPL ID 6c9e7e2a-5fb7-4e1b-813e-d0ab33a43502
Pharmacologic class: Expectorant; Sigma-1 Agonist; Uncompetitive N-methyl-D-aspartate Receptor Antagonist

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

N457237031251 followed by a unit qualifier and the quantity

Package 57237-0312-51. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under M012.85

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

FDA NDC Directory listings under M012.85
Product	Strength	Form · route	Labeler	Product NDC
Dextromethorphan HBr. and Guaifenesin	Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL	SolutionOral	Rising Pharma Holdings, Inc.	57237-313
Dextromethorphan HBr. and Guaifenesin	Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL	SolutionOral	Everpharm LLC	84415-011