montelukast sodium
HIGHLIGHTS OF PRESCRIBING INFORMATION 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: 1998
Approved
Approval ID
25b2049d-3a93-4ac3-8de6-14f5d7ce0315
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
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 Code50090-2921
Application NumberANDA204093
Product Classification
M
Marketing Category
C73584
G
Generic Name
montelukast sodium
Product Specifications
Route of AdministrationORAL
Effective DateJune 18, 2021
FDA Product Classification
INGREDIENTS (9)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MONTELUKASTActive
Quantity: 4 mg in 1 1
Code: MHM278SD3E
Classification: ACTIB