SINGULAIR

This brand name is authorized in Austria, Brazil, Canada, Cyprus, Germany, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Japan, Malta, Mexico, Netherlands, Poland, Romania, Singapore, Tunisia, Turkey, United Kingdom, United States, South Africa

Active ingredients

The drug SINGULAIR contains one active pharmaceutical ingredient (API):

1 Montelukast UNII U1O3J18SFL - MONTELUKAST SODIUM

Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Τhe CysLT type-1 (CysLT1) receptor is found in the human airway (including airway smooth muscle cells and airway macrophages) and on other pro-inflammatory cells (including eosinophils and certain myeloid stem cells). CysLTs have been correlated with the pathophysiology of asthma and allergic rhinitis. Read about Montelukast

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
SINGULAIR Tablet / Chewable Tablet / Granule	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
R03DC03	Montelukast	R Respiratory system → R03 Drugs for obstructive airway diseases → R03D Other systemic drugs for obstructive airway diseases → R03DC Leukotriene receptor antagonists
Discover more medicines within R03DC03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 525502001116218, 525502002112216, 525502003119214, 525502004115212, 525502005111210, 525502006118219, 525502007130311, 525502008137318
Country: CA	Health Products and Food Branch	Identifier(s): 02238216, 02238217, 02243602, 02247997
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 00364392, 00894813, 00894836, 01017534, 01017540, 01017557, 01160355, 01160361, 01160450, 01160473, 01160533, 01999744, 02286199, 02457666, 02457672, 02457689, 02471169, 02471181, 03644844, 03644867, 03644896, 03963213, 04073881, 04073898, 04073906, 04788108, 04788114, 04847070, 04847087, 04847093, 05523725, 05523731, 05523748, 05525492, 05525500, 05525517, 05748714, 06976469, 07578280, 08758541, 08758570, 09166825, 12738952, 14357303, 16023196, 16569498, 16569506, 16569512, 17448302
Country: EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	Identifier(s): 21.834-1-01-05, 21.835-1-01-05, 25.461-11-03, 25.630-04-04
Country: EE	Ravimiamet	Identifier(s): 1011283, 1077320, 1077331, 1077364, 1084520, 1084531, 1111082, 1454723, 1454734, 1454745, 1457872, 1457883, 1457894, 1457906, 1457917, 1457928, 1457939, 1457940, 1457951, 1457962, 1457973
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 61979, 61980, 63673, 65429, 7956, 7956IP, 7956IP1, 7956IP2, 7956IP3, 7957, 7957IP, 7957IP1, 7957IP2, 7957IP3, 8780
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 011526, 021048, 021345
Country: FR	Base de données publique des médicaments	Identifier(s): 62746747, 63842168, 64374772, 64561462, 64708962, 65324797, 67128676, 68069647, 69863646
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 140029, 140031, 140035, 143645, 143657, 143678, 21458, 21493, 21500, 373480, 373535, 373564, 377648, 67422
Country: HK	Department of Health Drug Office	Identifier(s): 43332, 43333, 47118, 51616
Country: HR	Agencija za lijekove i medicinske proizvode	Identifier(s): HR-H-436317310, HR-H-490892692, HR-H-556066749
Country: IE	Health Products Regulatory Authority	Identifier(s): 46237, 46334, 46542, 73002, 73011, 73013, 73091
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 3640, 3641, 4748, 6230
Country: IT	Agenzia del Farmaco	Identifier(s): 034001014, 034001026, 034001053, 034001216, 042170011, 043072014, 043637014, 043948013, 043948025, 043949015, 043954015
Country: JP	医薬品医療機器総合機構	Identifier(s): 4490026C1030, 4490026F1052, 4490026F2059, 4490026F3039, 4490026F4035
Country: MT	Medicines Authority	Identifier(s): AA908/13504, PI908/13501A, PI908/13502A, PI908/13503A
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 057M2002, 356M97, 357M97
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 52043, 52051, 67857, 90182
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100001350, 100082621, 100101985, 100209665
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68217001, W68217002, W68218001, W68218002, W68297001, W68297002, W68297003, W68297004, W68298001, W68298002, W68298003, W68298004, W68298005, W68298006, W68298007, W68298008, W68298009, W68298010, W68298011, W68298012, W68298013, W68298014, W68298015
Country: SG	Health Sciences Authority	Identifier(s): 09768P, 09769P, 11641P, 12460P
Country: TN	Direction de la Pharmacie et du Médicament	Identifier(s): 3443041, 7013083, 7013084, 7013085
Country: TR	İlaç ve Tıbbi Cihaz Kurumu	Identifier(s): 8699636080108, 8699636080122, 8699636090800
Country: US	FDA, National Drug Code	Identifier(s): 0006-1711, 0006-3841, 0006-9117, 0006-9275
Country: ZA	Health Products Regulatory Authority	Identifier(s): 32/10.2.2/0322, 35/10.2.2/0397, A38/10.2.2/0584