FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
71205-189
11-digit product format
712050189
Labeler code
71205
Product ID
71205-189_d746c647-bf7f-4443-bce5-465209a84d94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA200405
Marketing category
ANDA
Marketing start
2012-08-03
Substance
MONTELUKAST SODIUM
Active strength
4 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 SODIUM4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui311759

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
71205-189-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE302
71205-189-60Montelukast Sodium60 in 1 BOTTLETABLET, CHEWABLE602
71205-189-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-189-30EA - Each71205-18949742f58-e3d9-441f-9aed-b239f8b1d29712020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-189MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20210715_83c35a3d-0bbc-4598-bf76-ab0c2903bf19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311759montelukast sodium 4 MG Chewable TabletPSN83c35a3d-0bbc-4598-bf76-ab0c2903bf192
311759montelukast 4 MG Chewable TabletSCD83c35a3d-0bbc-4598-bf76-ab0c2903bf192
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY83c35a3d-0bbc-4598-bf76-ab0c2903bf192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-189-307120501893030 TABLET, CHEWABLE in 1 BOTTLE (71205-189-30) 2018-01-030000-00-00NoNoCurrent
71205-189-607120501896060 TABLET, CHEWABLE in 1 BOTTLE (71205-189-60) 2018-01-030000-00-00NoNoCurrent
71205-189-907120501899090 TABLET, CHEWABLE in 1 BOTTLE (71205-189-90) 2018-01-030000-00-00NoNoCurrent