Montelukast Sodium

Product NDC
68071-5141
11-digit product format
680715141
Labeler code
68071
Product ID
68071-5141_bbf54086-3db8-b88d-e053-2a95a90acb8e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090984
Marketing category
ANDA
Marketing start
2012-08-03
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
5 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5141-92024-06-20C16284748780-1f386c64a-307f-0266-e053-dadaa90a7c1a9b7e1b02-5c39-38e0-e053-2a95a90a813a
68071-5141-92023-01-30C16284748780-1f386c64a-307f-0266-e053-dadaa90a7c1a9b7e1b02-5c39-38e0-e053-2a95a90a813a

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5141-96807151410990 TABLET, CHEWABLE in 1 BOTTLE (68071-5141-9) 2020-01-060000-00-00NoNoCurrent