FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
71205-778
11-digit product format
712050778
Labeler code
71205
Product ID
71205-778_461f2aaa-e091-478e-97c1-27a089db8cdc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202468
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
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
71205-778-30Montelukast Sodium30 in 1 BOTTLETABLET, FILM COATED301
71205-778-60Montelukast Sodium60 in 1 BOTTLETABLET, FILM COATED601
71205-778-90Montelukast Sodium90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-778-30EA - Each71205-77823984de6-9b00-462a-92b9-8f4db95c932612026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-778MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]1Current NDC, 3 package rows20230323_461f2aaa-e091-478e-97c1-27a089db8cdc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN461f2aaa-e091-478e-97c1-27a089db8cdc1
200224montelukast 10 MG Oral TabletSCD461f2aaa-e091-478e-97c1-27a089db8cdc1
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY461f2aaa-e091-478e-97c1-27a089db8cdc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-778-307120507783030 TABLET, FILM COATED in 1 BOTTLE (71205-778-30) 2023-03-21NoNoCurrent
71205-778-607120507786060 TABLET, FILM COATED in 1 BOTTLE (71205-778-60) 2023-03-21NoNoCurrent
71205-778-907120507789090 TABLET, FILM COATED in 1 BOTTLE (71205-778-90) 2023-03-21NoNoCurrent