Amantadine
Amantadine Hydrochloride Tablets Rx only
Approved
Approval ID
da1837b5-fda2-48e0-91ba-d6eb2b991b55
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2023
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amantadine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-586
Application NumberANDA214284
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amantadine
Product Specifications
Route of AdministrationORAL
Effective DateApril 24, 2023
FDA Product Classification
INGREDIENTS (8)
AMANTADINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: M6Q1EO9TD0
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT