SINGULAIR
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 GranulesInitial U.S. Approval: 1998
Approved
Approval ID
e8d9021d-73aa-4c96-8b8a-e90069e78555
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
montelukast sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4847
Application NumberNDA020830
Product Classification
M
Marketing Category
C73594
G
Generic Name
montelukast sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
montelukast sodiumActive
Quantity: 5 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT
montelukast sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3283
Application NumberNDA020829
Product Classification
M
Marketing Category
C73594
G
Generic Name
montelukast sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (11)
montelukast sodiumActive
Quantity: 10 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
lactose monohydrateInactive
Quantity: 89.3 mg in 1 1
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
montelukast sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4630
Application NumberNDA020830
Product Classification
M
Marketing Category
C73594
G
Generic Name
montelukast sodium
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2012
FDA Product Classification
INGREDIENTS (8)
montelukast sodiumActive
Quantity: 4 mg in 1 1
Code: U1O3J18SFL
Classification: ACTIM
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
aspartameInactive
Code: Z0H242BBR1
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT