FDA.reportPublic FDA data

montelukast sodium

Product NDC
71205-181
11-digit product format
712050181
Labeler code
71205
Product ID
71205-181_226845ec-8ddf-4af4-912e-d71d79818165
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204290
Marketing category
ANDA
Marketing start
2016-01-01
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-181-30montelukast sodium30 in 1 BOTTLE, PLASTICTABLET, FILM COATED304
71205-181-60montelukast sodium60 in 1 BOTTLE, PLASTICTABLET, FILM COATED604
71205-181-90montelukast sodium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-181-30EA - Each71205-181aea2f8d0-218a-4d01-a8c0-ef46ce9b412912019-02-13
71205-181-90EA - Each71205-1816ff216ea-dd24-49d7-9db0-c2e8e6c8bc5612019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-181MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20220604_2ce48faf-4504-488a-8b20-3e8d4f008fb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN2ce48faf-4504-488a-8b20-3e8d4f008fb24
200224montelukast 10 MG Oral TabletSCD2ce48faf-4504-488a-8b20-3e8d4f008fb24
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2ce48faf-4504-488a-8b20-3e8d4f008fb24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-181-307120501813030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-181-30) 2018-12-010000-00-00NoNoCurrent
71205-181-607120501816060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-181-60) 2018-12-010000-00-00NoNoCurrent
71205-181-907120501819090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-181-90) 2018-12-010000-00-00NoNoCurrent