FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
16729-119
11-digit product format
167290119
Labeler code
16729
Product ID
16729-119_d481e75b-ffed-a218-e053-2995a90a19c5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA202717
Marketing category
ANDA
Marketing start
2013-04-11
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 Sodium
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
16729-119-10Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED3015
16729-119-15Montelukast Sodium90 in 1 BOTTLETABLET, FILM COATED9015
16729-119-17Montelukast Sodium1000 in 1 BOTTLETABLET, FILM COATED100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-119-10EA - Each16729-1194a1db3a1-c7f7-4314-87fe-e4cfa503ddde12013-05-02
16729-119-15EA - Each16729-1193cf8c7d4-068d-4686-8cff-6f1a5d5c9b3412013-05-02
16729-119-17EA - Each16729-1195561596e-d56f-4965-a47a-e9de33c8282012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-119MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]15Current NDC, Legacy NDC, 3 package rows20220102_6eea668f-a2fa-447f-b2d5-4c754d13d9fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNc9ec1996-6a54-4622-b8a6-57dea49f6b3522
200224montelukast 10 MG Oral TabletSCDc9ec1996-6a54-4622-b8a6-57dea49f6b3522
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYc9ec1996-6a54-4622-b8a6-57dea49f6b3522
200224montelukast sodium 10 MG Oral TabletPSN6eea668f-a2fa-447f-b2d5-4c754d13d9fa15
200224montelukast 10 MG Oral TabletSCD6eea668f-a2fa-447f-b2d5-4c754d13d9fa15
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY6eea668f-a2fa-447f-b2d5-4c754d13d9fa15
200224montelukast sodium 10 MG Oral TabletPSN4ba27278-6249-4546-9331-b19302cbf2db8
200224montelukast 10 MG Oral TabletSCD4ba27278-6249-4546-9331-b19302cbf2db8
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY4ba27278-6249-4546-9331-b19302cbf2db8
200224montelukast sodium 10 MG Oral TabletPSN97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e56
200224montelukast 10 MG Oral TabletSCD97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e56
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e56
200224montelukast sodium 10 MG Oral TabletPSNfdc5e630-3a01-4db6-8107-0e220dca2ba15
200224montelukast sodium 10 MG Oral TabletPSN549f1d1a-81f5-29f5-e054-00144ff8d46c5
200224montelukast 10 MG Oral TabletSCD549f1d1a-81f5-29f5-e054-00144ff8d46c5
200224montelukast 10 MG Oral TabletSCDfdc5e630-3a01-4db6-8107-0e220dca2ba15
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY549f1d1a-81f5-29f5-e054-00144ff8d46c5
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYfdc5e630-3a01-4db6-8107-0e220dca2ba15
200224montelukast sodium 10 MG Oral TabletPSN566a8fd7-fc00-2297-e054-00144ff8d46c4
200224montelukast sodium 10 MG Oral TabletPSN2de887d6-93b8-4309-a12d-d08d8b1ed5524
200224montelukast 10 MG Oral TabletSCD566a8fd7-fc00-2297-e054-00144ff8d46c4
200224montelukast 10 MG Oral TabletSCD2de887d6-93b8-4309-a12d-d08d8b1ed5524
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY566a8fd7-fc00-2297-e054-00144ff8d46c4
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2de887d6-93b8-4309-a12d-d08d8b1ed5524
200224montelukast sodium 10 MG Oral TabletPSN2fbdf1be-a37f-879b-e063-6394a90aa20d3
200224montelukast 10 MG Oral TabletSCD2fbdf1be-a37f-879b-e063-6394a90aa20d3
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2fbdf1be-a37f-879b-e063-6394a90aa20d3
200224montelukast sodium 10 MG Oral TabletPSNb8b86f2b-1fe3-4a58-9bf4-e826166609c32
200224montelukast 10 MG Oral TabletSCDb8b86f2b-1fe3-4a58-9bf4-e826166609c32
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYb8b86f2b-1fe3-4a58-9bf4-e826166609c32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-119-101672901191030 TABLET, FILM COATED in 1 BOTTLE (16729-119-10) 2013-06-110000-00-00NoNoCurrent
16729-119-151672901191590 TABLET, FILM COATED in 1 BOTTLE (16729-119-15) 2013-04-110000-00-00NoNoCurrent
16729-119-17167290119171000 TABLET, FILM COATED in 1 BOTTLE (16729-119-17) 2014-11-200000-00-00NoNoCurrent