FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
0093-7426
11-digit product format
000937426
Labeler code
0093
Product ID
0093-7426_7d53adbd-8c7e-4e6b-b310-353dd087fac3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA078605
Marketing category
ANDA
Marketing start
2012-08-03
Marketing end
2021-09-30
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7426-10EA - Each0093-7426696aa873-d8a2-4bec-a945-8c421f73a32312013-02-13
0093-7426-56EA - Each0093-74261f3bae87-05b1-4fb2-8dee-9b5385958ed312013-02-13
0093-7426-98EA - Each0093-7426bbfae67b-a86e-422a-ba01-e298d943a26712013-02-13

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
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [PHYSICIANS TOTAL CARE, INC.]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, FILM COATED [MEDVANTX, INC.]1

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
200224montelukast sodium 10 MG Oral TabletPSN09692f56-468c-4884-ae95-d2fb9d984e4c2
311759montelukast sodium 4 MG Chewable TabletPSN09692f56-468c-4884-ae95-d2fb9d984e4c2
242438montelukast sodium 5 MG Chewable TabletPSN09692f56-468c-4884-ae95-d2fb9d984e4c2
200224montelukast 10 MG Oral TabletSCD09692f56-468c-4884-ae95-d2fb9d984e4c2
311759montelukast 4 MG Chewable TabletSCD09692f56-468c-4884-ae95-d2fb9d984e4c2
242438montelukast 5 MG Chewable TabletSCD09692f56-468c-4884-ae95-d2fb9d984e4c2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY09692f56-468c-4884-ae95-d2fb9d984e4c2
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY09692f56-468c-4884-ae95-d2fb9d984e4c2
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY09692f56-468c-4884-ae95-d2fb9d984e4c2
200224montelukast sodium 10 MG Oral TabletPSNb24549cf-6c14-4e49-8756-5bd6d88ec6b81
200224montelukast 10 MG Oral TabletSCDb24549cf-6c14-4e49-8756-5bd6d88ec6b81
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYb24549cf-6c14-4e49-8756-5bd6d88ec6b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7426-10000937426101000 TABLET, FILM COATED in 1 BOTTLE (0093-7426-10) 2012-08-032021-06-30NoNoCurrent
0093-7426-560009374265630 TABLET, FILM COATED in 1 BOTTLE (0093-7426-56) 2012-08-032021-04-30NoNoCurrent
0093-7426-980009374269890 TABLET, FILM COATED in 1 BOTTLE (0093-7426-98) 2012-08-032021-09-30NoNoCurrent