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 Compound23663996pubchem.ncbi.nlm.nih.gov/compound/23663996
PubChem InChIKey SearchLBFBRXGCXUHRJY-HKHDRNBDSA-Mpubchem.ncbi.nlm.nih.gov/#query=LBFBRXGCXUHRJY-HKHDRNBDSA-M
RxNorm115713mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=115713
NCI ThesaurusC47625ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47625
FDA Substance Registration SystemU1O3J18SFLprecision.fda.gov/uniisearch/srs/unii/U1O3J18SFL

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
These 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
These 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
These 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
These 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
These 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
These 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
These 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 Montelukast Sodium Chewable Tablets Initial U.S. Approval:19981001
These 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
These 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
These 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
These 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
These 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: 19981000
These 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: 19981000
These 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
These 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
These 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
These 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
These 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
SINGULAIR® (MONTELUKAST SODIUM) TABLETS, CHEWABLE TABLETS, AND ORAL GRANULES1
SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3686
MONTELUKAST SODIUM TABLET, CHEWABLE [BRYANT RANCH PREPACK]1001
MONTELUKAST TABLET, FILM COATED [BRYANT RANCH PREPACK]1001
SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SINGULAIR (MONTELUKAST SODIUM) GRANULE SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]48
SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]26
SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]24
MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [KREMERS URBAN PHARMACEUTICALS INC.]21
MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [QUALITEST PHARMACEUTICALS]20
MONTELUKAST SODIUM TABLET, COATED MONTELUKAST SODIUM TABLET, CHEWABLE [DR.REDDY'S LABORATORIES LIMITED]17
MONTELUKAST SODIUM GRANULE [DR.REDDY'S LABORATORIES LIMITED]12
SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [A-S MEDICATION SOLUTIONS LLC]12
MONTELUKAST SODIUM GRANULE MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST) TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AJANTA PHARMA LIMITED]9
MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM GRANULE [MYLAN PHARMACEUTICALS INC.]9
MONTELUKAST TABLET, FILM COATED [INTERNATIONAL LABORATORIES, INC.]9
MONTELUKAST SODIUM TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]8
MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE [PD-RX PHARMACEUTICALS, INC.]7
MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [APOTEX CORP]7
MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]7
MONTELUKAST SODIUM TABLET, FILM COATED MONTELUKAST SODIUM TABLET, CHEWABLE [TEVA PHARMACEUTICALS USA INC]7
MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [SANDOZ INC]7
MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVKARE, INC.]6
MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]6
MONTELUKAST SODIUM TABLET, FILM COATED [ACCORD HEALTHCARE INC.]6
MONTELUKAST SODIUM GRANULE [PRASCO LABORATORIES]5
MONTELUKAST SODIUM (MONTELUKAST) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]4
MONTELUKAST SODIUM TABLET, CHEWABLE [CARILION MATERIALS MANAGEMENT]4
MONTELUKAST SODIUM TABLET, FILM COATED [BLUEPOINT LABORATORIES]4
MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MONTELUKAST TABLET [MACLEODS PHARMACEUTICALS LIMITED]3
SINGULAIR (MONTELUKAST SODIUM) GRANULE [REMEDYREPACK INC. ]3
MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET [PD-RX PHARMACEUTICALS, INC.]2
MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, CHEWABLE MONTELUKAST SODIUM (MONTELUKAST SODIUM) TABLET, FILM COATED [AVPAK]2
MONTELUKAST SODIUM TABLET [PROFICIENT RX LP]2
MONTELUKAST SODIUM TABLET [TORRENT PHARMACEUTICALS LIMITED]2
MONTELUKAST SODIUM TABLET MONTELUKAST SODIUM TABLET, CHEWABLE [ROXANE LABORATORIES, INC.]2
MONTELUKAST SODIUM TABLET, COATED [LEGACY PHARMACEUTICAL PACKAGING, LLC]2
MONTELUKAST SODIUM TABLET, FILM COATED [CARDINAL HEALTH]2
MONTELUKAST SODIUM TABLET, FILM COATED [CARDINAL HEALTH]2
MONTELUKAST SODIUM TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
MONTELUKAST TABLET, FILM COATED [CLINICAL SOLUTIONS WHOLESALE]2
MONTELUKAST TABLET, FILM COATED MONTELUKAST TABLET, CHEWABLE [BIONPHARMA INC.]2
SINGULAIR (MONTELUKAST SODIUM) GRANULE [REMEDYREPACK INC. ]2
SINGULAIR (MONTELUKAST SODIUM) TABLET, CHEWABLE SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [CARDINAL HEALTH]2
MONTELUKAST SODIUM CHEWABLE (MONTELUKAST SODIUM) TABLET, CHEWABLE [JUBILANT CADISTA PHARMACEUTICALS INC.]1
MONTELUKAST SODIUM TABLET [MAJOR PHARMACEUTICALS]1
MONTELUKAST SODIUM TABLET, CHEWABLE [PREFERRED PHARMACEUTICALS, INC.]1
MONTELUKAST SODIUM TABLET, CHEWABLE [PROFICIENT RX LP]1
MONTELUKAST SODIUM TABLET, CHEWABLE MONTELUKAST SODIUM TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MONTELUKAST SODIUM TABLET, FILM COATED [CARDINAL HEALTH]1
MONTELUKAST SODIUM TABLET, FILM COATED [DIRECT RX]1
MONTELUKAST SODIUM TABLET, FILM COATED [GEN-SOURCE RX]1
MONTELUKAST SODIUM TABLET, FILM COATED [LEGACY PHARMACEUTICAL PACKAGING]1
MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]1
MONTELUKAST SODIUM TABLET, FILM COATED [PROFICIENT RX LP]1
MONTELUKAST TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1
SINGULAIR (MONTELUKAST SODIUM) TABLET, FILM COATED [REMEDYREPACK INC. ]1