Amantadine Hydrochloride
Amantadine Hydrochloride Tablets, USP
Approved
Approval ID
e091bb11-c465-4402-9f2d-abefadd350e6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
REMEDYREPACK INC.
DUNS: 829572556
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
NDC Product Code70518-3381
Application NumberANDA076186
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic Nameamantadine hydrochloride
INGREDIENTS (8)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
STARCH, POTATOInactive
Code: 8I089SAH3T
Classification: IACT
AMANTADINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: M6Q1EO9TD0
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT