Amantadine HCl
Approved
Approval ID
c74c9424-278d-4a52-8866-db66f6c3ac67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 2, 2010
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code21695-564
Application NumberANDA078720
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amantadine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2010
FDA Product Classification
INGREDIENTS (11)
AMANTADINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: M6Q1EO9TD0
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT