MedPath

Amantadine Hydrochloride

AMANTADINE HYDROCHLORIDE ORAL SOLUTION, USP 50 mg/5 mL

Approved
Approval ID

97d6bd4a-31ca-4b33-8353-a536835ef1e1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

ATLANTIC BIOLOGICALS CORP.

DUNS: 047437707

FDA

Atlantic Biologicals Corps

DUNS: 047437707

Products 1

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
NDC Product Code17856-0093
Application NumberANDA075060
Product Classification
M
Marketing Category
C73584
G
Generic Name
AMANTADINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (17)

Trisodium Citrate DihydrateInactive
Code: B22547B95K
Classification: IACT
Amantadine HydrochlorideActive
Quantity: 50 mg in 5 mL
Code: M6Q1EO9TD0
Classification: ACTIB
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Anhydrous Citric AcidInactive
Code: XF417D3PSL
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
AMANTADINE HYDROCHLORIDEActive
Quantity: 50 mg in 5 mL
Code: M6Q1EO9TD0
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/8/2024

AMANTADINE HYDROCHLORIDE SOLUTION

image description

DESCRIPTION SECTION

LOINC: 34089-3Updated: 5/8/2024

DESCRIPTION

Amantadine hydrochloride, USP is designated chemically as 1-adamantanamine hydrochloride.

Chemical Structure

C10H17N • HCl M.W. 187.71

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.

Amantadine Hydrochloride Oral Solution, USP contains 50 mg of amantadine hydrochloride per 5 mL and has the following inactive ingredients: anhydrous citric acid, artificial raspberry flavor, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sodium citrate dihydrate, and sorbitol solution.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.