NDC Code(s) : 35356-169-09
Packager : Lake Erie Medical DBA Quality Care Products LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FrovaFrovatriptan succinate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:35356-169(NDC:63481-025)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FROVATRIPTAN SUCCINATE(UNII: D28J6W18HY)
(FROVATRIPTAN - UNII:H82Q2D5WA7) 		FROVATRIPTAN 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE(UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
TRIACETIN(UNII: XHX3C3X673)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color white Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code E;2;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:35356-169-099 in 1 BLISTER PACK Type 0: Not a Combination Product18/08/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021006 08/18/2010 06/01/2017

PRINCIPAL DISPLAY PANEL

image of label