Amantadine Hydrochloride
Amantadine Hydrochloride Capsules, USP Rx only
Approved
Approval ID
da693bb0-0cc8-485d-89a7-c8cf28d440f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2019
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-0020
Application NumberANDA071293
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amantadine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2016
FDA Product Classification
INGREDIENTS (17)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMANTADINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: M6Q1EO9TD0
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403C
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT