FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
13668-079
11-digit product format
136680079
Labeler code
13668
Product ID
13668-079_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA090984
Marketing category
ANDA
Marketing start
2012-08-03
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
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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-079-05Montelukast Sodium500 in 1 BOTTLETABLET, CHEWABLE50023
13668-079-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3023
13668-079-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-079-05EA - Each13668-079b8a59779-6f93-4a5b-a9c9-49d524b84b1112013-02-13
13668-079-30EA - Each13668-0797e6e4bd1-8955-4fd5-815c-517a4846fc5e12013-02-13
13668-079-90EA - Each13668-07943003472-b16a-4cb6-851c-c0612033588e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
CHERRYINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
CHERRYINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
CHERRYINACTIVE INGREDIENTBUC5I9595WMONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-079MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED]22Current NDC, Legacy NDC, 3 package rows20250529_da038cf6-cfad-43a4-ab8e-d81d028d6087.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSNc69ab399-8ea6-4002-9271-b6a57c862b1427
311759montelukast 4 MG Chewable TabletSCDc69ab399-8ea6-4002-9271-b6a57c862b1427
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYc69ab399-8ea6-4002-9271-b6a57c862b1427
200224montelukast sodium 10 MG Oral TabletPSNda038cf6-cfad-43a4-ab8e-d81d028d608723
311759montelukast sodium 4 MG Chewable TabletPSNda038cf6-cfad-43a4-ab8e-d81d028d608723
351246montelukast sodium 4 MG Oral GranulesPSNda038cf6-cfad-43a4-ab8e-d81d028d608723
242438montelukast sodium 5 MG Chewable TabletPSNda038cf6-cfad-43a4-ab8e-d81d028d608723
200224montelukast 10 MG Oral TabletSCDda038cf6-cfad-43a4-ab8e-d81d028d608723
311759montelukast 4 MG Chewable TabletSCDda038cf6-cfad-43a4-ab8e-d81d028d608723
351246montelukast 4 MG Oral GranulesSCDda038cf6-cfad-43a4-ab8e-d81d028d608723
242438montelukast 5 MG Chewable TabletSCDda038cf6-cfad-43a4-ab8e-d81d028d608723
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYda038cf6-cfad-43a4-ab8e-d81d028d608723
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSYda038cf6-cfad-43a4-ab8e-d81d028d608723
351246montelukast 4 MG (as montelukast sodium 4.2 MG) Oral GranulesSYda038cf6-cfad-43a4-ab8e-d81d028d608723
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYda038cf6-cfad-43a4-ab8e-d81d028d608723
311759montelukast sodium 4 MG Chewable TabletPSN07d5fbea-b183-41c9-a20f-30da1f44ab1b4
311759montelukast 4 MG Chewable TabletSCD07d5fbea-b183-41c9-a20f-30da1f44ab1b4
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY07d5fbea-b183-41c9-a20f-30da1f44ab1b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-079-0513668007905500 TABLET, CHEWABLE in 1 BOTTLE (13668-079-05) 2012-08-030000-00-00NoNoCurrent
13668-079-301366800793030 TABLET, CHEWABLE in 1 BOTTLE (13668-079-30) 2012-08-030000-00-00NoNoCurrent
13668-079-7413668007974100 TABLET, CHEWABLE in 1 CARTON (13668-079-74) 2012-08-030000-00-00NoNoCurrent
13668-079-901366800799090 TABLET, CHEWABLE in 1 BOTTLE (13668-079-90) 2012-08-030000-00-00NoNoCurrent