Amantadine Hydrochloride NDC 10135-693

NDC codes

FDA NDC Directory

Product NDC (as listed)10135-693Labeler and product segments. Claims need a package NDC.

Product NDC at billing width10135-0693Add 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
10135-693-01	10135069301	100 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-01)Marketed from Mar 1, 2020
10135-693-05	10135069305	500 CAPSULE, GELATIN COATED in 1 BOTTLE (10135-693-05)Marketed from Mar 1, 2020

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 — 100 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Marlex Pharmaceuticals Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210129
Marketing start: Mar 1, 2020
Listing expires: Dec 31, 2026
Other FDA classes: M2 Protein Inhibitors (Mechanism)
Identifiers: Product ID 10135-693_3e752827-026e-d525-e063-6394a90a7e80SPL ID 3e752827-026e-d525-e063-6394a90a7e80SPL set ID 25af52ee-9b29-4c07-a383-62d4537b63e0RxCUI 849389, 849395UNII 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

N410135069301 followed by a unit qualifier and the quantity

Package 10135-0693-01. 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

Current FDA label (SPL), effective Sep 10, 2025.

Indications (excerpt from the label)

INDICATIONS AND USAGE Amantadine Hydrochloride are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine Hydrochloride are also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. Influenza a Prophylaxis Amantadine Hydrochloride are indicated for chemoprophylaxis against signs and symptoms of influenza a virus infection. Because Amantadine Hydrochloride do 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 exposed to antige…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210129

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

FDA NDC Directory listings under ANDA 210129
Product	Strength	Form · route	Labeler	Product NDC
Amantadine Hydrochloride	Amantadine hydrochloride 100 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-834
Amantadine HCL	Amantadine hydrochloride 100 mg/1	CapsuleOral	Direct RX	72189-657