FDA.reportPublic FDA data

MONTELUKAST

Substance profile for UNII MHM278SD3E, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for MONTELUKAST
Structure render from PubChem CID 5281040

Substance Identity#

UNII
MHM278SD3E
Preferred term
MONTELUKAST
Registry number
158966-92-8
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C35H36ClNO3S
Chemical structure for MONTELUKAST
Structure render from PubChem CID 5281040

Chemical And Database Identifiers#

InChIKey
UCHDWCPVSPXUMX-TZIWLTJVSA-N
SMILES
CC(C)(O)C1=CC=CC=C1CC[C@@H](SCC2(CC(O)=O)CC2)C3=CC=CC(\C=C\C4=CC=C5C=CC(Cl)=CC5=N4)=C3
RxCUI
88249
PubChem
5281040
NCIt
C66189
INN ID
7388

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound5281040pubchem.ncbi.nlm.nih.gov/compound/5281040
PubChem InChIKey SearchUCHDWCPVSPXUMX-TZIWLTJVSA-Npubchem.ncbi.nlm.nih.gov/#query=UCHDWCPVSPXUMX-TZIWLTJVSA-N
RxNorm88249mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=88249
NCI ThesaurusC66189ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C66189
FDA Substance Registration SystemMHM278SD3Eprecision.fda.gov/uniisearch/srs/unii/MHM278SD3E

DailyMed Socrata Ingredients#

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