MONTELUKAST SODIUM

Product NDC
61919-097
11-digit product format
619190097
Labeler code
61919
Product ID
61919-097_9ca98d44-0398-f379-e053-2995a90a9cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
DIRECT RX
Application
ANDA090984
Marketing category
ANDA
Marketing start
2017-03-29
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-097-302023-01-30C16284748780-1f386c64a-3ee6-0266-e053-dadaa90a7c1aMONTELUKAST SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-097-30MONTELUKAST SODIUM30 in 1 BOTTLETABLET, CHEWABLE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-097-30EA - Each61919-097f77f7b9b-bdbe-4376-a446-f17b2ec1091912019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-097MONTELUKAST SODIUM TABLET, CHEWABLE [DIRECT RX]2Legacy NDC, 1 package rows20200122_4be31c8e-81ea-11d2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSN4be31c8e-81ea-11d2-e054-00144ff8d46c2
242438montelukast 5 MG Chewable TabletSCD4be31c8e-81ea-11d2-e054-00144ff8d46c2
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY4be31c8e-81ea-11d2-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-097-306191900973030 TABLET, CHEWABLE in 1 BOTTLE (61919-097-30) 2017-03-290000-00-00NoNoCurrent