Amantadine Hydrochloride NDC 60687-797

NDC codes

FDA NDC Directory

Product NDC (as listed)60687-797Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60687-0797Add 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
60687-797-56	60687079756	10 TRAY in 1 CASE (60687-797-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-797-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-797-42)Marketed from Feb 26, 2024

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 Hydrochloride
Generic name (nonproprietary): amantadine hydrochloride
Active ingredients: Amantadine hydrochloride — 50 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: American Health Packaging
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074509
Marketing start: Feb 26, 2024
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 60687-797_11e80915-df52-1580-e063-6394a90a67b1SPL ID 11e80915-df52-1580-e063-6394a90a67b1SPL set ID 5a8f16cc-e5d5-4097-8297-10c8166c7a0eRxCUI 849385UNII 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

N460687079756 followed by a unit qualifier and the quantity

Package 60687-0797-56. 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 Feb 21, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amantadine hydrochloride oral solution USP is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride is also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions. Influenza A Prophylaxis Amantadine hydrochloride is 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 may be protected when later …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074509

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

FDA NDC Directory listings under ANDA 074509
Product	Strength	Form · route	Labeler	Product NDC
Amantadine Hydrochloride	Amantadine hydrochloride 50 mg/5mL	SolutionOral	ATLANTIC BIOLOGICALS CORP.	17856-0646
Amantadine Hydrochloride	Amantadine hydrochloride 50 mg/5mL	SolutionOral	Cardinal Health 107, LLC	55154-9444
Amantadine Hydrochloride	Amantadine hydrochloride 50 mg/5mL	SolutionOral	PAI Holdings, LLC dba PAI Pharma	0121-0646