Basic Information
montelukast sodium
29300-220
Regulatory Information
29300-220
ANDA204290
C73584
June 12, 2023
USA
These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral useMONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998
HUMAN PRESCRIPTION DRUG LABEL
17
Company Information
181620514
Active Ingredients
CARNAUBA WAX
Code: R12CBM0EIZ
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
FERRIC OXIDE RED
Code: 1K09F3G675
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
MANNITOL
Code: 3OWL53L36A
Class Code: IACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED
Code: 9XZ8H6N6OH
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
MICROCRYSTALLINE CELLULOSE 112
Code: X7XJ6RM9Q2
Class Code: IACT
Active Moieties
MONTELUKAST
Code: MHM278SD3E