FDA.reportPublic FDA data

Montelukast

Product NDC
54458-890
11-digit product format
544580890
Labeler code
54458
Product ID
54458-890_027c648e-3e87-4458-9973-d305db3aefed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA078605
Marketing category
ANDA
Marketing start
2013-10-04
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
E
Listing certified through
2018-12-31
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
54458-890-102020-01-31C16284748780-19d75b9d0-331f-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets and chewable tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-890-10Montelukast30 in 1 BLISTER PACKTABLET, FILM COATED3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-890-10EA - Each54458-890b5bcd318-df9e-415c-9813-a2b41a5df76412013-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-890MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, LLC]14Legacy NDC, 1 package rows20170609_bfa9d526-6c07-4391-96a7-e8c6d6e4b573.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNbfa9d526-6c07-4391-96a7-e8c6d6e4b57314
200224montelukast 10 MG Oral TabletSCDbfa9d526-6c07-4391-96a7-e8c6d6e4b57314
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYbfa9d526-6c07-4391-96a7-e8c6d6e4b57314

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
54458-890-105445808901030 in 1 BLISTER PACKHistorical