FDA.reportPublic FDA data

Montelukast

Product NDC
68071-1561
11-digit product format
680711561
Labeler code
68071
Product ID
68071-1561_cbe4397e-83d8-1369-e053-2995a90a0777
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202843
Marketing category
ANDA
Marketing start
2014-09-10
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
2022-12-31
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
68071-1561-32025-01-30C16284748780-1f386c64a-1e9c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998
68071-1561-32023-07-14C16284748780-1f386c64a-1e9c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998
68071-1561-32023-01-30C16284748780-1f386c64a-1e9c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS. MONTELUKAST SODIUM tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-1561-3Montelukast30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-1561MONTELUKAST TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Legacy NDC, 1 package rows20230715_cbe40638-2489-5812-e053-2995a90a236c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNcbe40638-2489-5812-e053-2995a90a236c2
200224montelukast 10 MG Oral TabletSCDcbe40638-2489-5812-e053-2995a90a236c2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYcbe40638-2489-5812-e053-2995a90a236c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-1561-36807115610330 TABLET, FILM COATED in 1 BOTTLE (68071-1561-3) 2021-09-130000-00-00NoNoCurrent