FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
13668-081
11-digit product format
136680081
Labeler code
13668
Product ID
13668-081_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA201515
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
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 SODIUM10 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
13668-081-05Montelukast Sodium500 in 1 BOTTLETABLET50023
13668-081-30Montelukast Sodium30 in 1 BOTTLETABLET3023
13668-081-32Montelukast Sodium3200 in 1 BOTTLETABLET320023
13668-081-74Montelukast Sodium100 in 1 CARTONTABLET10023
13668-081-90Montelukast Sodium90 in 1 BOTTLETABLET9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-081-05EA - Each13668-0817d32680a-babc-44e6-8bc9-08ca76c31e3f12013-07-02
13668-081-30EA - Each13668-081f38e190e-7ebc-4fb0-9333-8f00479d071312013-02-11
13668-081-32EA - Each13668-0818023249e-c4dd-42f2-82f7-52a7ed4caba212013-07-02
13668-081-90EA - Each13668-08166bcef20-fd63-40af-a355-cc1ec4637f7e12013-02-11

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
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-081MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM GRANULE [TORRENT PHARMACEUTICALS LIMITED]22Current NDC, Legacy NDC, 5 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
200224montelukast sodium 10 MG Oral TabletPSN8a724790-e1fb-4935-bb28-ce99455be5ef4
200224montelukast 10 MG Oral TabletSCD8a724790-e1fb-4935-bb28-ce99455be5ef4
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY8a724790-e1fb-4935-bb28-ce99455be5ef4
200224montelukast sodium 10 MG Oral TabletPSN64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2
200224montelukast 10 MG Oral TabletSCD64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-081-0513668008105500 TABLET in 1 BOTTLE (13668-081-05) 500 tablet2012-08-030000-00-00NoNoCurrent
13668-081-301366800813030 TABLET in 1 BOTTLE (13668-081-30) 30 tablet2012-08-030000-00-00NoNoCurrent
13668-081-32136680081323200 TABLET in 1 BOTTLE (13668-081-32) 3200 tablet2012-08-030000-00-00NoNoCurrent
13668-081-7413668008174100 TABLET in 1 CARTON (13668-081-74) 100 tablet2012-08-030000-00-00NoNoCurrent
13668-081-901366800819090 TABLET in 1 BOTTLE (13668-081-90) 90 tablet2012-08-030000-00-00NoNoCurrent