Amantadine HCl (amantadine hydrochloride) NDC 42291-125

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-125Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0125Add 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
42291-125-50	42291012550	500 CAPSULE, LIQUID FILLED in 1 BOTTLE (42291-125-50)Marketed from Aug 7, 2013

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): Amantadine HCl
Generic name (nonproprietary): amantadine hydrochloride
Active ingredients: Amantadine hydrochloride — 100 mg/1
Dosage form: Capsule, Liquid filled
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078720
Marketing start: Aug 7, 2013
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 42291-125_38569431-56b5-5f56-e063-6394a90ad24fSPL ID 38569431-56b5-5f56-e063-6394a90ad24fSPL set ID bfd129ae-8b0a-f118-b7d0-45d106290b63RxCUI 849389UNII M6Q1EO9TD0
Pharmacologic class: Influenza A M2 Protein Inhibitor

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

N442291012550 followed by a unit qualifier and the quantity

Package 42291-0125-50. 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 24, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amantadine Hydrochloride Capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride Capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis: Amantadine Hydrochloride Capsules, USP are indicated for chemoprophylaxis against signs and symptoms of influenza A virus infection. Because Amantadine Hydrochloride does not completely prevent the host immune response to influenza A infection, individuals who take this drug may still develop immune responses to natural disease or vaccination and …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078720

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

FDA NDC Directory listings under ANDA 078720
Product	Strength	Form · route	Labeler	Product NDC
Amantadine HClamantadine hydrochloride	Amantadine hydrochloride 100 mg/1	Capsule, Liquid filledOral	Bionpharma Inc.	69452-142
Amantadine HClamantadine hydrochloride	Amantadine hydrochloride 100 mg/1	Capsule, Liquid filledOral	AvPAK	50268-069