FDA.reportPublic FDA data

SINGULAIR

Product NDC
21695-221
11-digit product format
216950221
Labeler code
21695
Product ID
21695-221_78eea56d-15a6-4ceb-b755-d1a3e9707f32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA020829
Marketing category
NDA
Marketing start
1998-02-20
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
E
Listing certified through
2017-12-31
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
21695-221-302019-09-24C16284748780-1934fe258-4b57-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use SINGULAIR safely and effectively. See full prescribing information for SINGULAIR. SINGULAIR ® (montelukast sodium) tablets, chewable tablets, and oral granules Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-221-30SINGULAIR30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-221-30EA - Each21695-22129cd059b-78aa-446c-9834-1306b75b243012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
montelukastACTIVE MOIETYMHM278SD3ESINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
aspartameINACTIVE INGREDIENTZ0H242BBR1SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
hydroxypropyl celluloseINACTIVE INGREDIENTRFW2ET671PSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
mannitolINACTIVE INGREDIENT3OWL53L36ASINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-221SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_78eea56d-15a6-4ceb-b755-d1a3e9707f32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200224montelukast sodium 10 MG Oral TabletPSN78eea56d-15a6-4ceb-b755-d1a3e9707f321
242438montelukast sodium 5 MG Chewable TabletPSN78eea56d-15a6-4ceb-b755-d1a3e9707f321
153892Singulair 10 MG Oral TabletPSN78eea56d-15a6-4ceb-b755-d1a3e9707f321
153893Singulair 5 MG Chewable TabletPSN78eea56d-15a6-4ceb-b755-d1a3e9707f321
153892montelukast 10 MG Oral Tablet [Singulair]SBD78eea56d-15a6-4ceb-b755-d1a3e9707f321
153893montelukast 5 MG Chewable Tablet [Singulair]SBD78eea56d-15a6-4ceb-b755-d1a3e9707f321
200224montelukast 10 MG Oral TabletSCD78eea56d-15a6-4ceb-b755-d1a3e9707f321
242438montelukast 5 MG Chewable TabletSCD78eea56d-15a6-4ceb-b755-d1a3e9707f321
200224montelukast 10 MG (as montelukast sodium 10.4 MG) Oral TabletSY78eea56d-15a6-4ceb-b755-d1a3e9707f321
242438montelukast 5 MG (as montelukast sodium 5.2 MG) Chewable TabletSY78eea56d-15a6-4ceb-b755-d1a3e9707f321
153892Singulair 10 MG (montelukast sodium 10.4 MG) Oral TabletSY78eea56d-15a6-4ceb-b755-d1a3e9707f321
153892Singulair 10 MG Oral TabletSY78eea56d-15a6-4ceb-b755-d1a3e9707f321
153893Singulair 5 MG (montelukast sodium 5.2 MG) Chewable TabletSY78eea56d-15a6-4ceb-b755-d1a3e9707f321
153893Singulair 5 MG Chewable TabletSY78eea56d-15a6-4ceb-b755-d1a3e9707f321

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-221-302169502213030 in 1 BOTTLEHistorical