Montelukast Sodium

Product NDC
70436-091
11-digit product format
704360091
Labeler code
70436
Product ID
70436-091_a672fe2a-6e74-1a83-e053-2995a90a9610
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC.
Application
ANDA205695
Marketing category
ANDA
Marketing start
2018-03-13
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
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70436-091-062023-02-17C16284748780-1d6a99b39-3e9c-a426-e053-dadaa90af4c23309e256-85a5-4e04-8c72-ebe1dfa277dd
70436-091-062022-01-28C16284748780-1d6a99b39-3e9c-a426-e053-dadaa90af4c23309e256-85a5-4e04-8c72-ebe1dfa277dd

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-091-06EA - Each70436-09116788a61-b429-44e4-bb44-ef4c7dc0777412019-01-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-091-067043600910690 TABLET, CHEWABLE in 1 BOTTLE (70436-091-06) 2018-03-130000-00-00NoNoCurrent