FDA.reportPublic FDA data

Montelukast

Product NDC
0781-5560
11-digit product format
007815560
Labeler code
0781
Product ID
0781-5560_e593fadb-cac5-44ca-8fd6-93c626cd40a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA200889
Marketing category
ANDA
Marketing start
2012-08-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Montelukast
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-5560-06Montelukast10 in 1 BLISTER PACKTABLET, FILM COATED1015
0781-5560-13Montelukast10 in 1 CARTONTABLET, FILM COATED1015
0781-5560-31Montelukast30 in 1 BOTTLETABLET, FILM COATED3015
0781-5560-92Montelukast90 in 1 BOTTLETABLET, FILM COATED9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-5560-31EA - Each0781-556076e59a27-0faa-42dd-b2e1-eaa047f27cac12013-02-13
0781-5560-92EA - Each0781-55601c260048-a465-4f77-a3b1-d38b9d50dcc112013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
LACTIC ACIDINACTIVE INGREDIENT33X04XA5ATMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
SUCROSEINACTIVE INGREDIENTC151H8M554MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNe67c211a-cee7-41e8-9a2a-32d7363ef2a31002
200224montelukast 10 MG Oral TabletSCDe67c211a-cee7-41e8-9a2a-32d7363ef2a31002
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYe67c211a-cee7-41e8-9a2a-32d7363ef2a31002
200224montelukast sodium 10 MG Oral TabletPSN6d69e73a-76cb-4ece-9cf9-e9adb4f523b415
200224montelukast 10 MG Oral TabletSCD6d69e73a-76cb-4ece-9cf9-e9adb4f523b415
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY6d69e73a-76cb-4ece-9cf9-e9adb4f523b415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-5560-060078155600610 in 1 BLISTER PACKHistorical
0781-5560-130078155601310 BLISTER PACK in 1 CARTON (0781-5560-13) / 10 TABLET, FILM COATED in 1 BLISTER PACK (0781-5560-06) 10 blister pack2025-06-130000-00-00NoNoCurrent
0781-5560-310078155603130 TABLET, FILM COATED in 1 BOTTLE (0781-5560-31) 2025-06-130000-00-00NoNoCurrent
0781-5560-920078155609290 TABLET, FILM COATED in 1 BOTTLE (0781-5560-92) 2025-06-130000-00-00NoNoCurrent