FDA.reportPublic FDA data

MONTELUKAST SODIUM

Product NDC
71205-128
11-digit product format
712050128
Labeler code
71205
Product ID
71205-128_03b5d63d-1c2c-41db-8111-2dcf7e66f010
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA203328
Marketing category
ANDA
Marketing start
2015-08-13
Substance
MONTELUKAST SODIUM
Active strength
5 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 SODIUM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui242438

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
71205-128-30MONTELUKAST SODIUM30 in 1 BOTTLETABLET, CHEWABLE303
71205-128-60MONTELUKAST SODIUM60 in 1 BOTTLETABLET, CHEWABLE603
71205-128-90MONTELUKAST SODIUM90 in 1 BOTTLETABLET, CHEWABLE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-128-90EA - Each71205-128cfd4e0d7-e05a-4e97-8094-5af6159f588112018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-128MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20191023_cab84c43-96a3-4868-88da-3126685edf00.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSNcab84c43-96a3-4868-88da-3126685edf003
242438montelukast 5 MG Chewable TabletSCDcab84c43-96a3-4868-88da-3126685edf003
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYcab84c43-96a3-4868-88da-3126685edf003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-128-307120501283030 TABLET, CHEWABLE in 1 BOTTLE (71205-128-30) 2018-10-010000-00-00NoNoCurrent
71205-128-607120501286060 TABLET, CHEWABLE in 1 BOTTLE (71205-128-60) 2018-10-010000-00-00NoNoCurrent
71205-128-907120501289090 TABLET, CHEWABLE in 1 BOTTLE (71205-128-90) 2018-10-010000-00-00NoNoCurrent