FDA.reportPublic FDA data

MONTELUKAST SODIUM

Product NDC
61919-009
11-digit product format
619190009
Labeler code
61919
Product ID
61919-009_f200a4c8-a6d4-86e0-e053-2a95a90a5a4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MONTELUKAST SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA202717
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2024-12-31
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
61919-009-302025-01-30C16284748780-12cef2736-9039-d83d-e063-dadaa90ab31fMONTELUKAST SODIUM
61919-009-902025-01-30C16284748780-12cef2736-9039-d83d-e063-dadaa90ab31fMONTELUKAST SODIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-009-30MONTELUKAST SODIUM30 in 1 BOTTLETABLET, FILM COATED304
61919-009-90MONTELUKAST SODIUM90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-009-30EA - Each61919-0091a45f9cd-e8dc-4b95-95ad-e26b10983f0912019-11-12
61919-009-90EA - Each61919-0093c407b7a-9a03-4433-8d90-f1ff4a624e8112014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
MONTELUKASTACTIVE MOIETYMHM278SD3EMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
HYDROXYPROPYL CELLULOSE (TYPE L)INACTIVE INGREDIENTUKE75GEA7FMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-009MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]4Legacy NDC, 2 package rows20230112_2de887d6-93b8-4309-a12d-d08d8b1ed552.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN2de887d6-93b8-4309-a12d-d08d8b1ed5524
200224montelukast 10 MG Oral TabletSCD2de887d6-93b8-4309-a12d-d08d8b1ed5524
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY2de887d6-93b8-4309-a12d-d08d8b1ed5524

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-009-306191900093030 TABLET, FILM COATED in 1 BOTTLE (61919-009-30) 2014-01-010000-00-00NoNoCurrent
61919-009-906191900099090 TABLET, FILM COATED in 1 BOTTLE (61919-009-90) 2015-01-010000-00-00NoNoCurrent