FDA.reportPublic FDA data

MONTELUKAST SODIUM

Product NDC
27241-016
11-digit product format
272410016
Labeler code
27241
Product ID
27241-016_c7998daa-0220-4f57-a2b7-a2e468b10471
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA203328
Marketing category
ANDA
Marketing start
2015-08-13
Substance
MONTELUKAST SODIUM
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MONTELUKAST SODIUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui200224, 242438, 311759, 351246

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
27241-016-03MONTELUKAST SODIUM30 in 1 BOTTLETABLET, CHEWABLE3020
27241-016-09MONTELUKAST SODIUM90 in 1 BOTTLETABLET, CHEWABLE9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-016-03EA - Each27241-0166fec0ec9-7ca8-40aa-88e5-5586c79a8df212015-12-02
27241-016-09EA - Each27241-016f7956595-6c54-48c8-8c71-09f86a0c50ef12015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-016MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA USA INC.]19Current NDC, Legacy NDC, 2 package rows20211123_67070e4e-f755-46b3-b900-fcc1993a0546.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN67070e4e-f755-46b3-b900-fcc1993a054620
311759montelukast sodium 4 MG Chewable TabletPSN67070e4e-f755-46b3-b900-fcc1993a054620
351246montelukast sodium 4 MG Oral GranulesPSN67070e4e-f755-46b3-b900-fcc1993a054620
242438montelukast sodium 5 MG Chewable TabletPSN67070e4e-f755-46b3-b900-fcc1993a054620
200224montelukast 10 MG Oral TabletSCD67070e4e-f755-46b3-b900-fcc1993a054620
311759montelukast 4 MG Chewable TabletSCD67070e4e-f755-46b3-b900-fcc1993a054620
351246montelukast 4 MG Oral GranulesSCD67070e4e-f755-46b3-b900-fcc1993a054620
242438montelukast 5 MG Chewable TabletSCD67070e4e-f755-46b3-b900-fcc1993a054620
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY67070e4e-f755-46b3-b900-fcc1993a054620
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY67070e4e-f755-46b3-b900-fcc1993a054620
351246montelukast 4 MG (as montelukast sodium 4.2 MG) Oral GranulesSY67070e4e-f755-46b3-b900-fcc1993a054620
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY67070e4e-f755-46b3-b900-fcc1993a054620
311759montelukast sodium 4 MG Chewable TabletPSN54014b67-3163-4c8f-b93a-229cd231ca6b3
311759montelukast 4 MG Chewable TabletSCD54014b67-3163-4c8f-b93a-229cd231ca6b3
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY54014b67-3163-4c8f-b93a-229cd231ca6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-016-032724100160330 TABLET, CHEWABLE in 1 BOTTLE (27241-016-03) 2015-08-130000-00-00NoNoCurrent
27241-016-092724100160990 TABLET, CHEWABLE in 1 BOTTLE (27241-016-09) 2015-08-130000-00-00NoNoCurrent