Montelukast Sodium

Product NDC
0093-7487
11-digit product format
000937487
Labeler code
0093
Product ID
0093-7487_e439ab83-caf7-4853-981d-e648277733b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
GRANULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA090955
Marketing category
ANDA
Marketing start
2017-12-13
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7487-19EA - Each0093-7487ee113742-0e03-42e2-ae71-dfd372fc85a812018-01-12
0093-7487-56EA - Each0093-7487360488ce-c5c5-4e72-99f3-e8eccca8c23112018-01-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-7487-560009374875630 PACKET in 1 CARTON (0093-7487-56) > 1 GRANULE in 1 PACKET (0093-7487-19) 30 packet2017-12-130000-00-00NoNoCurrent