FDA.reportPublic FDA data

Montelukast Sodium

Product NDC
70934-485
11-digit product format
709340485
Labeler code
70934
Product ID
70934-485_a82616ca-766c-de36-e053-2995a90a6228
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Montelukast Sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA200405
Marketing category
ANDA
Marketing start
2020-05-08
Marketing end
0000-00-00
Substance
MONTELUKAST SODIUM
Active strength
5 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
8d8a355b-240d-8c38-7331-c9e3c1068a33Product name920161220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70934-485-302022-01-28C16284748780-1d6a99b39-74f0-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use MONTELUKAST SODIUM safely and effectively. See full prescribing information for MONTELUKAST SODIUM. MONTELUKAST SODIUM tablets, for oral use MONTELUKAST SODIUM chewable tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-485-30Montelukast Sodium30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-485-30EA - Each70934-485e4ff5bdb-208c-4bce-a92b-63e687c79c8512023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-485MONTELUKAST SODIUM TABLET, CHEWABLE [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 1 package rows20200617_a8261a89-d35b-357e-e053-2a95a90afcd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSNa8261a89-d35b-357e-e053-2a95a90afcd01
242438montelukast 5 MG Chewable TabletSCDa8261a89-d35b-357e-e053-2a95a90afcd01
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSYa8261a89-d35b-357e-e053-2a95a90afcd01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70934-485-307093404853030 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70934-485-30) 2020-05-080000-00-00NoNoCurrent