SINGULAIR

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

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 more about Montelukast

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

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