FDA.reportPublic FDA data

montelukast sodium

Product NDC
29300-221
11-digit product format
293000221
Labeler code
29300
Product ID
29300-221_57f07f65-1a14-4423-9da8-975664ca0684
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Unichem Pharmaceuticals (USA), Inc.
Application
ANDA208621
Marketing category
ANDA
Marketing start
2018-08-20
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
29300-221-10montelukast sodium1000 in 1 BOTTLE, PLASTICTABLET, CHEWABLE100017
29300-221-13montelukast sodium30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE3017
29300-221-19montelukast sodium90 in 1 BOTTLE, PLASTICTABLET, CHEWABLE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
29300-221-10EA - Each29300-221c1398784-73be-4d04-905a-3f46ccca7e6212019-01-24
29300-221-13EA - Each29300-2216b0758a6-004c-4f0a-b8c7-4a988877185912019-01-24
29300-221-19EA - Each29300-2216c827be7-b75b-43f3-aa9a-a9fc7a132f1812019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
29300-221MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [UNICHEM PHARMACEUTICALS (USA), INC.]17Current NDC, Legacy NDC, 3 package rows20230625_9e375c07-70db-458c-9336-22a7037b0a5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast sodium 4 MG Chewable TabletPSN9e375c07-70db-458c-9336-22a7037b0a5f17
242438montelukast sodium 5 MG Chewable TabletPSN9e375c07-70db-458c-9336-22a7037b0a5f17
200224montelukast 10 MG Oral TabletSCD9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast 4 MG Chewable TabletSCD9e375c07-70db-458c-9336-22a7037b0a5f17
242438montelukast 5 MG Chewable TabletSCD9e375c07-70db-458c-9336-22a7037b0a5f17
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY9e375c07-70db-458c-9336-22a7037b0a5f17
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY9e375c07-70db-458c-9336-22a7037b0a5f17
311759montelukast sodium 4 MG Chewable TabletPSN239fe323-16f0-2a1d-e063-6394a90acff31
311759montelukast 4 MG Chewable TabletSCD239fe323-16f0-2a1d-e063-6394a90acff31
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY239fe323-16f0-2a1d-e063-6394a90acff31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
29300-221-10293000221101000 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-10) 2018-08-200000-00-00NoNoCurrent
29300-221-132930002211330 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-13) 2018-08-200000-00-00NoNoCurrent
29300-221-192930002211990 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (29300-221-19) 2018-08-200000-00-00NoNoCurrent