Dextromethorphan Polistirex Extended-Release NDC 65162-799

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-799Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0799Add 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
65162-799-76	65162079976	1 BOTTLE in 1 CARTON (65162-799-76) / 89 mL in 1 BOTTLEMarketed from Aug 1, 2017
65162-799-77	65162079977	1 BOTTLE in 1 CARTON (65162-799-77) / 148 mL in 1 BOTTLEMarketed from Aug 1, 2017

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 Polistirex Extended-Release
Generic name (nonproprietary): dextromethorphan polistirex
Active ingredients: Dextromethorphan hydrobromide — 30 mg/5mL
Dosage form: Suspension
Route: Oral
Labeler: Amneal Pharmaceuticals LLC
Product type: Over-the-counter drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 203133
Marketing start: Aug 1, 2017
Listing expires: Dec 31, 2026
Other FDA classes: Sigma-1 Receptor Agonists (Mechanism)Uncompetitive NMDA Receptor Antagonists (Mechanism)
Identifiers: Product ID 65162-799_9eb36122-c3bf-4b04-84a1-bb137f884c40SPL ID 9eb36122-c3bf-4b04-84a1-bb137f884c40SPL set ID e0104a59-0bc2-4401-8c14-7f28499dbac6RxCUI 1373045UNII 9D2RTI9KYH
Pharmacologic class: 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

N465162079976 followed by a unit qualifier and the quantity

Package 65162-0799-76. 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 Jun 27, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Uses Temporarily relieves cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants the impulse to cough to help you get to sleep

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203133

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

FDA NDC Directory listings under ANDA 203133
Product	Strength	Form · route	Labeler	Product NDC
Dextromethorphan Polistirex Extended-Releasedextromethorphan polistirex	Dextromethorphan hydrobromide 30 mg/5mL	SuspensionOral	Amneal Pharmaceuticals LLC	65162-700