Amantadine HCl (amantadine hydrochloride) NDC 50268-069

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-069Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0069Add 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
50268-069-15	50268006915	50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-069-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (50268-069-11)Marketed from Mar 28, 2014

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: AvPAK
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078720
Marketing start: Mar 28, 2014
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 50268-069_38566e1f-b7b1-540f-e063-6394a90a2760SPL ID 38566e1f-b7b1-540f-e063-6394a90a2760SPL set ID 461e6444-189e-62ed-6c61-1c36a04459c6RxCUI 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

N450268006915 followed by a unit qualifier and the quantity

Package 50268-0069-15. 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	AvKARE	42291-125