Amantadine Hydrochloride
Amantadine Hydrochloride Capsules-Tablets
25af52ee-9b29-4c07-a383-62d4537b63e0
HUMAN PRESCRIPTION DRUG LABEL
Sep 10, 2025
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amantadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Amantadine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (12)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
NDC 10135-0693-05
MARLEX
Amantadine Hydrochloride
Capsules, USP
100 mg
Rx Only
500 Tablets
DESCRIPTION SECTION
DESCRIPTION
Amantadine hydrochloride is designated generically as amantadine hydrochloride and chemically as 1-adamantanamine hydrochloride.
C10H17N•HCl
Amantadine hydrochloride is a stable white or nearly white crystalline powder, freely soluble in water and soluble in alcohol and in chloroform.
Amantadine hydrochloride has pharmacological actions as both an anti-Parkinson and an antiviral drug.
Each tablet intended for oral administration contains 100 mg amantadine hydrochloride and has the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, magnesium stearate, and colloidal silicon dioxide.
Each capsule intended for oral administration contains 100 mg amantadine hydrochloride and has the following inactive ingredients: magnesium stearate, microcrystalline cellulose, Povidone, Sodium Starch Glycolate, Colloidal Silicon Dioxide. The capsule shells and imprinting ink contain FD&C Blue #1, FD&C Red #40, gelatin, FD&C Yellow #6, sodium lauryl sulfate, and titanium dioxide.