Amantadine Hydrochloride
AMANTADINE HYDROCHLORIDE TABLET
Approved
Approval ID
5ae327cf-8946-4682-9025-64653673e367
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
Athem LLC
DUNS: 117077124
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 Code73152-075
Application NumberANDA210215
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amantadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (6)
MICROCRYSTALLINE CELLULOSEInactive
Quantity: 26 1 in 1 1
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Quantity: 3 1 in 1 1
Code: AG9B65PV6B
Classification: IACT
POVIDONEInactive
Quantity: 3 1 in 1 1
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Quantity: 0.8 1 in 1 1
Code: 70097M6I30
Classification: IACT
AMANTADINE HYDROCHLORIDEActive
Quantity: 100 1 in 1 1
Code: M6Q1EO9TD0
Classification: ACTIB
SILICON DIOXIDEInactive
Quantity: 0.53 1 in 1 1
Code: ETJ7Z6XBU4
Classification: IACT