Basic Information
Montelukast Sodium
42254-263
Regulatory Information
42254-263
ANDA201522
C73584
July 23, 2012
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 and Chewable TabletsInitial U.S. approval: 1998
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
118802834
Active Ingredients
silicon dioxide
Code: ETJ7Z6XBU4
Class Code: IACT
cellulose, microcrystalline
Code: OP1R32D61U
Class Code: IACT
croscarmellose sodium
Code: M28OL1HH48
Class Code: IACT
hydroxypropyl cellulose (type h)
Code: RFW2ET671P
Class Code: IACT
polyethylene glycols
Code: 3WJQ0SDW1A
Class Code: IACT
mannitol
Code: 3OWL53L36A
Class Code: IACT
polyvinyl alcohol
Code: 532B59J990
Class Code: IACT
talc
Code: 7SEV7J4R1U
Class Code: IACT
sodium stearyl fumarate
Code: 7CV7WJK4UI
Class Code: IACT
titanium dioxide
Code: 15FIX9V2JP
Class Code: IACT
Active Moieties
Montelukast
Code: MHM278SD3E