Over-the-counter drug · OTC MONOGRAPH DRUG
Dextromethorphan HBr. and Guaifenesin NDC 57237-313
Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL · Solution · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57237-313-18 | 5723703131857237031318 | 80 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
- Brand name (proprietary)
- Dextromethorphan HBr. and Guaifenesin
- 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
N457237031318followed by a unit qualifier and the quantityPackage 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.
Related NDCs: other Dextromethorphan HBr. and Guaifenesin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Dextromethorphan HBr. and Guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Everpharm LLC | 84415-014 | 84415-0014-01 |
| Dextromethorphan HBr. and Guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-312 | 57237-0312-51 |
| Dextromethorphan HBr. and Guaifenesin | Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL | SolutionOral | Everpharm LLC | 84415-011 | 84415-0011-01 |
Other NDCs under M012.85
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Dextromethorphan HBr. and Guaifenesin | Dextromethorphan hydrobromide 10 mg/5mL; Guaifenesin 100 mg/5mL | SolutionOral | Rising Pharma Holdings, Inc. | 57237-312 |
| Dextromethorphan HBr. and Guaifenesin | Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL | SolutionOral | Everpharm LLC | 84415-011 |