FDA.reportPublic FDA data

MONTELUKAST SODIUM

Substance profile for UNII U1O3J18SFL, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for MONTELUKAST SODIUM
Structure render from PubChem CID 23663996

Substance Identity#

UNII
U1O3J18SFL
Preferred term
MONTELUKAST SODIUM
Registry number
151767-02-1
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C35H35ClNO3S.Na
Chemical structure for MONTELUKAST SODIUM
Structure render from PubChem CID 23663996

Chemical And Database Identifiers#

InChIKey
LBFBRXGCXUHRJY-HKHDRNBDSA-M
SMILES
[Na+].CC(C)(O)C1=CC=CC=C1CC[C@@H](SCC2(CC([O-])=O)CC2)C3=CC(\C=C\C4=CC=C5C=CC(Cl)=CC5=N4)=CC=C3
RxCUI
115713
PubChem
23663996
NCIt
C47625
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound23663996https://pubchem.ncbi.nlm.nih.gov/compound/23663996
PubChem InChIKey SearchLBFBRXGCXUHRJY-HKHDRNBDSA-Mhttps://pubchem.ncbi.nlm.nih.gov/#query=LBFBRXGCXUHRJY-HKHDRNBDSA-M
RxNorm115713https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=115713
NCI ThesaurusC47625https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47625
FDA Substance Registration SystemU1O3J18SFLhttps://precision.fda.gov/uniisearch/srs/unii/U1O3J18SFL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Chewable Tablets, for oral use Initial U.S. Approval: 19982
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS safely and effectively. See full prescribing information for MONTELUKAST SODIUM TABLETS and MONTELUKAST SODIUM CHEWABLE TABLETS. Montelukast Sodium Tablets, for oral use. Montelukast Sodium Chewable Tablets, for oral use. Initial U.S. Approval: 19983
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 19981
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium tablets. MONTELUKAST sodium tablets, for oral use Initial U.S. Approval: 19986
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 199817
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets Initial U.S. approval: 1998 --------- RECENT MAJOR CHANGES --------------- Warnings and Precautions Neuropsychiatric Events (5.4) 03/20131
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium tablets. montelukast sodium tablets Initial U.S. Approval: 19981
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use montelukast sodium tablets safely and effectively. See full prescribing information for montelukast sodium tablets. Montelukast Sodium Tablets Initial U.S. Approval: 19981
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast Sodium Tablets and Chewable Tablets Initial U.S. Approval: 19981
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 19981
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use montelukast sodium safely and effectively. See full prescribing information for montelukast sodium. MONTELUKAST SODIUM tablets and chewable tablets for oral use Initial U.S. Approval: 19982
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLThese highlights do not include all the information needed to use Montelukast sodium safely and effectively. See full prescribing information for Montelukast sodium. Montelukast sodium Tablets and Chewable Tablets Initial U.S. approval: 19981
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLThese 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: 19981
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLThese 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: 19981
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES1
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3686
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK]1000
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [BRYANT RANCH PREPACK]1000
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]48
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]26
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS]20
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]12
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM GRANULE [MYLAN PHARMACEUTICALS INC.]9
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]8
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [APOTEX CORP]7
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]7
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]4
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [BLUEPOINT LABORATORIES]4
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) GRANULE [REMEDYREPACK INC. ]3
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET [PD-RX PHARMACEUTICALS, INC.]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [CARDINAL HEALTH]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [CARDINAL HEALTH]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.]2
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) GRANULE [REMEDYREPACK INC. ]2
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [CARDINAL HEALTH]2
montelukast sodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET [MAJOR PHARMACEUTICALS]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
Montelukast SodiumACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [CARDINAL HEALTH]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [GEN-SOURCE RX]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLMONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
MONTELUKAST SODIUMACTIVE INGREDIENTU1O3J18SFLSINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REMEDYREPACK INC. ]1