FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
13668-531
11-digit product format
136680531
Labeler code
13668
Product ID
13668-531_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
GRANULE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA210431
Marketing category
ANDA
Marketing start
2017-03-30
Substance
MONTELUKAST SODIUM
Active strength
4 mg/500mg
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/500mg

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
13668-531-11Montelukast Sodium500 mg in 1 PACKETGRANULE50023
13668-531-94Montelukast Sodium30 in 1 CARTONGRANULE3023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-531-11EA - Each13668-531ac0dd939-f29a-4c21-9ff1-33afb145801d12018-11-06
13668-531-94EA - Each13668-5316f90087b-509c-4bb2-9b3d-720a75be4eb712019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-531MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED]22Current NDC, Legacy NDC, 2 package rows20250529_da038cf6-cfad-43a4-ab8e-d81d028d6087.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-531-1113668053111500 mg in 1 PACKET500 mgHistorical
13668-531-941366805319430 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11) 30 packet2017-03-300000-00-00NoNoCurrent