NDC Code(s) : 54569-0084-2, 54569-0084-3
Packager : A-S Medication Solutions LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Amantadine HydrochlorideAmantadine Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-0084(NDC:0781-2048)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANTADINE HYDROCHLORIDE(UNII: M6Q1EO9TD0)
(AMANTADINE - UNII:BF4C9Z1J53) 		AMANTADINE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (7 MPA.S)(UNII: H3UP11403C)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHYLPARABEN(UNII: A2I8C7HI9T)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code GG634
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-0084-214 in 1 BOTTLE
2NDC:54569-0084-310 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA071293 02/18/1987

PRINCIPAL DISPLAY PANEL

NDC 54569-0084-2

Packaged by:
A-S Medication Solutions
Libertyville, IL 60048


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