FDA.reportPublic FDA data

montelukast sodium

Product NDC
68788-7669
11-digit product format
687887669
Labeler code
68788
Product ID
68788-7669_f9ab7e9f-ce5e-4c52-919e-66602d0c719e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204093
Marketing category
ANDA
Marketing start
2020-02-28
Substance
MONTELUKAST
Active strength
5 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 sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMHM278SD3E
Rxcui242438

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
68788-7669-1montelukast sodium10 in 1 BOTTLETABLET, CHEWABLE106
68788-7669-2montelukast sodium20 in 1 BOTTLETABLET, CHEWABLE206
68788-7669-3montelukast sodium30 in 1 BOTTLETABLET, CHEWABLE306
68788-7669-4montelukast sodium14 in 1 BOTTLETABLET, CHEWABLE146
68788-7669-6montelukast sodium60 in 1 BOTTLETABLET, CHEWABLE606
68788-7669-9montelukast sodium90 in 1 BOTTLETABLET, CHEWABLE906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7669-1EA - Each68788-7669d130ce6b-a2ca-45d0-a0a8-17e7747895cc12020-05-08
68788-7669-2EA - Each68788-76697464d2ce-011e-4809-8c93-bd9002fb3eb912020-05-08
68788-7669-3EA - Each68788-76697f8181e8-7f69-4d34-a1cb-390fe7cba86b12020-05-08
68788-7669-4EA - Each68788-76696fced204-8cfd-4b4a-9661-6e6b836bf86612020-05-08
68788-7669-6EA - Each68788-766955367211-9966-44f2-a1cb-1b734d89400712020-05-08
68788-7669-9EA - Each68788-766953c0e2ee-c978-4e3c-880d-1dd89588f57012020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7669MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 6 package rows20240724_09b0bc9e-3035-45b4-b61b-4aca70848360.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242438montelukast sodium 5 MG Chewable TabletPSN09b0bc9e-3035-45b4-b61b-4aca708483606
242438montelukast 5 MG Chewable TabletSCD09b0bc9e-3035-45b4-b61b-4aca708483606
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY09b0bc9e-3035-45b4-b61b-4aca708483606

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7669-16878876690110 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-1) 2020-02-280000-00-00NoNoCurrent
68788-7669-26878876690220 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-2) 2020-02-280000-00-00NoNoCurrent
68788-7669-36878876690330 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-3) 2020-02-280000-00-00NoNoCurrent
68788-7669-46878876690414 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-4) 2020-02-280000-00-00NoNoCurrent
68788-7669-66878876690660 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-6) 2020-02-280000-00-00NoNoCurrent
68788-7669-96878876690990 TABLET, CHEWABLE in 1 BOTTLE (68788-7669-9) 2020-02-280000-00-00NoNoCurrent