What is NDC 84415-011?

84415-011 is the product NDC for Dextromethorphan HBr. and Guaifenesin, Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL solution, listed with the FDA by Everpharm LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What is the active ingredient?

Dextromethorphan hydrobromide, Guaifenesin.

Everpharm LLC, NDC labeler code 84415. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Dextromethorphan HBr. and Guaifenesin NDC 84415-011

NDC codes

FDA NDC Directory

Product NDC (as listed)84415-011Labeler and product segments. Claims need a package NDC.

Product NDC at billing width84415-0011Add 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
84415-011-01	8441500110184415001101	100 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (84415-011-01) / 10 mL in 1 CUP, UNIT-DOSEMarketed 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: Everpharm LLCNDC labeler code 84415
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M012.85
Marketing start: Jun 12, 2023
Listing expires: Dec 31, 2026
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 84415-011_5cca83db-66f8-4029-e063-6394a90aa7a0SPL ID 5cca83db-66f8-4029-e063-6394a90aa7a0
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

N484415001101 followed by a unit qualifier and the quantity

Package 84415-0011-01. 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 84415-011

What is NDC 84415-011?: 84415-011 is the product NDC for Dextromethorphan HBr. and Guaifenesin, Dextromethorphan hydrobromide 20 mg/10mL; Guaifenesin 200 mg/10mL solution, listed with the FDA by Everpharm LLC. 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?: Everpharm LLC, NDC labeler code 84415. 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
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	Rising Pharma Holdings, Inc.	57237-313	57237-0313-18

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 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	Rising Pharma Holdings, Inc.	57237-313