NDC Code(s) : 68645-466-54
Packager : Legacy Pharmaceutical Packaging, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Montelukast SodiumMontelukast Sodium TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-466(NDC:55111-725)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM(UNII: U1O3J18SFL)
(MONTELUKAST - UNII:MHM278SD3E) 		MONTELUKAST10 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
HYPROMELLOSES(UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE RED(UNII: 1K09F3G675)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
Product Characteristics
Color BROWN Score no score
Shape SQUARE Size 4 mm
Flavor Imprint Code R;725
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68645-466-5430 in 1 BOTTLE Type 0: Not a Combination Product08/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201582 08/06/2012 03/31/2019

PRINCIPAL DISPLAY PANEL

Montelukast Sodium Tablets USP 10mg