FDA.reportPublic FDA data

SINGULAIR

Product NDC
78206-172
11-digit product format
782060172
Labeler code
78206
Product ID
78206-172_57a12189-3bb3-4a5d-b5fe-fc57db87c134
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Organon LLC
Application
NDA020829
Marketing category
NDA
Marketing start
2021-06-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SINGULAIR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MONTELUKAST SODIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU1O3J18SFL
Rxcui153892, 153893, 200224, 242438, 261367, 311759, 351246, 404406

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
78206-172-01SINGULAIR30 in 1 BOTTLETABLET, FILM COATED305
78206-172-02SINGULAIR90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-172-01EA - Each78206-1725a59402b-deaf-470e-82ae-7c9f182ae68612021-08-05
78206-172-02EA - Each78206-17215670ffd-60c9-4819-a895-f3f61ced3ae512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-172SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [ORGANON LLC]4Current NDC, Legacy NDC, 2 package rows20241017_482dcc92-b47f-4ea6-854a-f5ac2aea7842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
311759montelukast sodium 4 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
351246montelukast sodium 4 MG Oral GranulesPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
242438montelukast sodium 5 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892Singulair 10 MG Oral TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367Singulair 4 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406Singulair 4 MG Oral GranulesPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893Singulair 5 MG Chewable TabletPSN482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892montelukast 10 MG Oral Tablet [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367montelukast 4 MG Chewable Tablet [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406montelukast 4 MG Oral Granules [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893montelukast 5 MG Chewable Tablet [Singulair]SBD482dcc92-b47f-4ea6-854a-f5ac2aea78425
200224montelukast 10 MG Oral TabletSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
311759montelukast 4 MG Chewable TabletSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
351246montelukast 4 MG Oral GranulesSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
242438montelukast 5 MG Chewable TabletSCD482dcc92-b47f-4ea6-854a-f5ac2aea78425
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
311759montelukast 4 MG (as montelukast sodium 4.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
351246montelukast 4 MG (as montelukast sodium 4.2 MG) Oral GranulesSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892Singulair 10 MG (montelukast sodium 10.4 MG) Oral TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153892Singulair 10 MG Oral TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367Singulair 4 MG (montelukast sodium 4.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406Singulair 4 MG (montelukast sodium 4.2 MG) Oral GranulesSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
261367Singulair 4 MG Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
404406Singulair 4 MG Oral GranulesSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893Singulair 5 MG (montelukast sodium 5.2 MG) Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425
153893Singulair 5 MG Chewable TabletSY482dcc92-b47f-4ea6-854a-f5ac2aea78425

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
78206-172-017820601720130 TABLET, FILM COATED in 1 BOTTLE (78206-172-01) 2021-06-010000-00-00NoNoCurrent
78206-172-027820601720290 TABLET, FILM COATED in 1 BOTTLE (78206-172-02) 2021-06-010000-00-00NoNoCurrent