NDC codes

FDA NDC Directory
Product NDC (as listed)57237-313Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0313Add 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
57237-313-18572370313185723703131880 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (57237-313-18) / 10 mL in 1 CUP, UNIT-DOSE (57237-313-01)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

Generic name (nonproprietary)
dextromethorphan hbr. and guaifenesin
Active ingredients
Dextromethorphan hydrobromide — 20 mg/10mLGuaifenesin — 200 mg/10mL
Dosage form
Solution
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M012.85
Marketing start
Listing expires
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 57237-313_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

N457237031318 followed by a unit qualifier and the quantity

Package 57237-0313-18. 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.

About NDC 57237-313

What is NDC 57237-313?
57237-313 is the product NDC for Dextromethorphan HBr. and Guaifenesin, Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL solution, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Dextromethorphan HBr. and Guaifenesin.
What is the active ingredient?
Dextromethorphan hydrobromide, Guaifenesin.
Who is the labeler?
Rising Pharma Holdings, Inc., NDC labeler code 57237. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Dextromethorphan HBr. and Guaifenesin?
3 other product NDCs are listed under this name. See all Dextromethorphan HBr. and Guaifenesin 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 Dextromethorphan HBr. and Guaifenesin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Dextromethorphan HBr. and GuaifenesinDextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mLSolutionOralEverpharm LLC84415-01484415-0014-01
Dextromethorphan HBr. and GuaifenesinDextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mLSolutionOralRising Pharma Holdings, Inc.57237-31257237-0312-51
Dextromethorphan HBr. and GuaifenesinDextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mLSolutionOralEverpharm LLC84415-01184415-0011-01

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
ProductStrengthForm · routeLabelerProduct NDC
Dextromethorphan HBr. and GuaifenesinDextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mLSolutionOralRising Pharma Holdings, Inc.57237-312
Dextromethorphan HBr. and GuaifenesinDextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mLSolutionOralEverpharm LLC84415-011

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