FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
64205-655
11-digit product format
642050655
Labeler code
64205
Product ID
64205-655_07f02165-c20c-47bb-aba1-481feb397058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
ReadyMeds
Application
ANDA091576
Marketing category
ANDA
Marketing start
2012-08-03
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
2017-12-31
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
64205-655-302019-11-27C16284748780-19855e2a2-3c4e-60a7-e053-dbdaa90a05bdThese 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 Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-655-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED3017

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
HYPROMELLOSE 2208 (100 MPA.S)INACTIVE INGREDIENTB1QE5P712KMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-655MONTELUKAST SODIUM TABLET, FILM COATED [READYMEDS]17Legacy NDC, 1 package rows20140630_488e08d7-59d8-499e-bac6-a0783651d67b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN488e08d7-59d8-499e-bac6-a0783651d67b17
200224montelukast 10 MG Oral TabletSCD488e08d7-59d8-499e-bac6-a0783651d67b17
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY488e08d7-59d8-499e-bac6-a0783651d67b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-655-306420506553030 in 1 BOTTLEHistorical