FDA.reportPublic FDA data

montelukast sodium

Product NDC
67046-468
11-digit product format
670460468
Labeler code
67046
Product ID
67046-468_59b9449b-3ad0-39f7-e053-2a91aa0a6db2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA204290
Marketing category
ANDA
Marketing start
2017-09-21
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
10 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67046-468-072022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-142022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-152022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-202022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-212022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-282022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-302022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998
67046-468-602022-01-28C16284748780-1d6a99b39-d015-a426-e053-dadaa90af4c2468 Montelukast 10 mg These highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS USP safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS USP . MONTELUKAST sodium tablets USP, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-468-07montelukast sodium7 in 1 BLISTER PACKTABLET, FILM COATED71
67046-468-14montelukast sodium14 in 1 BLISTER PACKTABLET, FILM COATED141
67046-468-15montelukast sodium15 in 1 BLISTER PACKTABLET, FILM COATED151
67046-468-20montelukast sodium20 in 1 BLISTER PACKTABLET, FILM COATED201
67046-468-21montelukast sodium21 in 1 BLISTER PACKTABLET, FILM COATED211
67046-468-28montelukast sodium28 in 1 BLISTER PACKTABLET, FILM COATED281
67046-468-30montelukast sodium30 in 1 BLISTER PACKTABLET, FILM COATED301
67046-468-60montelukast sodium60 in 1 BLISTER PACKTABLET, FILM COATED601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-468MONTELUKAST SODIUM TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 8 package rows20170922_59b9449b-3acf-39f7-e053-2a91aa0a6db2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN59b9449b-3acf-39f7-e053-2a91aa0a6db21
200224montelukast 10 MG Oral TabletSCD59b9449b-3acf-39f7-e053-2a91aa0a6db21
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY59b9449b-3acf-39f7-e053-2a91aa0a6db21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67046-468-07670460468077 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-07) 2017-09-210000-00-00NoNoCurrent
67046-468-146704604681414 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-14) 2017-09-210000-00-00NoNoCurrent
67046-468-156704604681515 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-15) 2017-09-210000-00-00NoNoCurrent
67046-468-206704604682020 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-20) 2017-09-210000-00-00NoNoCurrent
67046-468-216704604682121 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-21) 2017-09-210000-00-00NoNoCurrent
67046-468-286704604682828 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-28) 2017-09-210000-00-00NoNoCurrent
67046-468-306704604683030 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-30) 2017-09-210000-00-00NoNoCurrent
67046-468-606704604686060 TABLET, FILM COATED in 1 BLISTER PACK (67046-468-60) 2017-09-210000-00-00NoNoCurrent