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
NDC Product Code21695-564
Application NumberANDA078720
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 6, 2010
Generic NameAmantadine hydrochloride
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