FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
63187-781
11-digit product format
631870781
Labeler code
63187
Product ID
63187-781_e36b33e0-a969-46fc-8a6a-c62f4ae61607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
63187-781-14Montelukast Sodium14 in 1 BOTTLETABLET, FILM COATED146
63187-781-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED306
63187-781-60Montelukast Sodium60 in 1 BOTTLETABLET, FILM COATED606
63187-781-90Montelukast Sodium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-781-14EA - Each63187-7812b331ab5-ec56-46d5-bd57-d7334e4874a012018-11-06
63187-781-30EA - Each63187-781599fbb44-4d4d-4596-a471-ded2c05d2bce12017-07-07
63187-781-90EA - Each63187-781cb437677-b68c-4e22-8a91-aa01f628c8c712017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-781MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 4 package rows20220513_97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-781-146318707811414 TABLET, FILM COATED in 1 BOTTLE (63187-781-14) 2018-09-040000-00-00NoNoCurrent
63187-781-306318707813030 TABLET, FILM COATED in 1 BOTTLE (63187-781-30) 2016-11-010000-00-00NoNoCurrent
63187-781-606318707816060 TABLET, FILM COATED in 1 BOTTLE (63187-781-60) 2016-11-010000-00-00NoNoCurrent
63187-781-906318707819090 TABLET, FILM COATED in 1 BOTTLE (63187-781-90) 2016-11-010000-00-00NoNoCurrent