FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
57237-212
11-digit product format
572370212
Labeler code
57237
Product ID
57237-212_1da56873-29ff-4b62-bebb-123a87d0e042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA202096
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
Rxcui200224, 242438, 311759

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
57237-212-30Montelukast Sodium30 in 1 BOTTLETABLET, CHEWABLE3010
57237-212-90Montelukast Sodium90 in 1 BOTTLETABLET, CHEWABLE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-212-30EA - Each57237-212314661e1-f527-4421-a081-ce9dd05c20ff12016-01-13
57237-212-90EA - Each57237-212d62cc1e9-c6c0-4216-b81b-9353e263794512016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-212MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]10Current NDC, Legacy NDC, 2 package rows20240406_49669ac0-0bb5-4576-bed5-9e85e0d76a44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN49669ac0-0bb5-4576-bed5-9e85e0d76a4410
311759montelukast sodium 4 MG Chewable TabletPSN49669ac0-0bb5-4576-bed5-9e85e0d76a4410
242438montelukast sodium 5 MG Chewable TabletPSN49669ac0-0bb5-4576-bed5-9e85e0d76a4410
200224montelukast 10 MG Oral TabletSCD49669ac0-0bb5-4576-bed5-9e85e0d76a4410
311759montelukast 4 MG Chewable TabletSCD49669ac0-0bb5-4576-bed5-9e85e0d76a4410
242438montelukast 5 MG Chewable TabletSCD49669ac0-0bb5-4576-bed5-9e85e0d76a4410
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY49669ac0-0bb5-4576-bed5-9e85e0d76a4410
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY49669ac0-0bb5-4576-bed5-9e85e0d76a4410
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY49669ac0-0bb5-4576-bed5-9e85e0d76a4410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-212-305723702123030 TABLET, CHEWABLE in 1 BOTTLE (57237-212-30) 2012-08-030000-00-00NoNoCurrent
57237-212-905723702129090 TABLET, CHEWABLE in 1 BOTTLE (57237-212-90) 2012-08-030000-00-00NoNoCurrent