FDA.reportPublic FDA data

Montelukast

Product NDC
70518-3133
11-digit product format
705183133
Labeler code
70518
Product ID
70518-3133_4e92e21f-c616-d5db-e063-6394a90aebcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202843
Marketing category
ANDA
Marketing start
2021-06-18
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Montelukast
Listing expiration
2027-12-31

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
70518-3133-0Montelukast90 in 1 BOTTLE, PLASTICTABLET, FILM COATED909
70518-3133-1Montelukast30 in 1 BLISTER PACKTABLET, FILM COATED309
70518-3133-2Montelukast30 in 1 BOTTLE, PLASTICTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3133MONTELUKAST TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 3 package rows20240314_ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSNecaa9b4b-5941-4af5-930c-35e9f3b2b4ba9
200224montelukast 10 MG Oral TabletSCDecaa9b4b-5941-4af5-930c-35e9f3b2b4ba9
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSYecaa9b4b-5941-4af5-930c-35e9f3b2b4ba9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3133-07051831330090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-0) 2021-06-180000-00-00NoNoCurrent
70518-3133-17051831330130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3133-1) 2021-07-010000-00-00NoNoCurrent
70518-3133-27051831330230 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-2) 2025-08-27NoNoCurrent