Montelukast Sodium

Product NDC
68788-6946
11-digit product format
687886946
Labeler code
68788
Product ID
68788-6946_8b1a8e54-8f6f-45b2-a77b-51cc54369af9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA090984
Marketing category
ANDA
Marketing start
2017-04-17
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-6946-16878869460110 TABLET, CHEWABLE in 1 BOTTLE (68788-6946-1) 2017-04-170000-00-00NoNoCurrent
68788-6946-26878869460220 TABLET, CHEWABLE in 1 CARTON (68788-6946-2) 2017-04-170000-00-00NoNoCurrent
68788-6946-36878869460330 TABLET, CHEWABLE in 1 BOTTLE (68788-6946-3) 2017-04-170000-00-00NoNoCurrent
68788-6946-46878869460414 TABLET, CHEWABLE in 1 BOTTLE (68788-6946-4) 2017-04-170000-00-00NoNoCurrent
68788-6946-66878869460660 TABLET, CHEWABLE in 1 BOTTLE (68788-6946-6) 2017-04-170000-00-00NoNoCurrent
68788-6946-96878869460990 TABLET, CHEWABLE in 1 BOTTLE (68788-6946-9) 2017-04-170000-00-00NoNoCurrent