NDC Code(s) : 63187-550-30, 63187-550-60, 63187-550-90
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Montelukast SodiumMontelukast Sodium TABLET, CHEWABLE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-550(NDC:13668-079)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MONTELUKAST SODIUM(UNII: U1O3J18SFL)
(MONTELUKAST - UNII:MHM278SD3E) 		MONTELUKAST4 mg
Inactive Ingredients
Ingredient Name Strength
ASPARTAME(UNII: Z0H242BBR1)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
CHERRY(UNII: BUC5I9595W)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FERRIC OXIDE RED(UNII: 1K09F3G675)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
Product Characteristics
Color PINK (Pink) Score no score
Shape OVAL (Oval) Size 9 mm
Flavor Imprint Code 1079;4
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63187-550-3030 in 1 BOTTLE Type 0: Not a Combination Product12/01/2018
2NDC:63187-550-6060 in 1 BOTTLE Type 0: Not a Combination Product12/01/2018
3NDC:63187-550-9090 in 1 BOTTLE Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090984 08/03/2012

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(63187-550), RELABEL(63187-550)

PRINCIPAL DISPLAY PANEL

Montelukast Sodium Chewable Tablets 4 mg

63187-550-30