MONTELUKAST SODIUM
MONTELUKAST SODIUM
Approved
Approval ID
c2d834e6-7b38-d266-e053-2995a90a27ef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2021
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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
NDC Product Code72189-223
Application NumberANDA204093
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 21, 2021
Generic NameMONTELUKAST SODIUM
INGREDIENTS (9)
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CHERRYInactive
Code: BUC5I9595W
Classification: IACT
MONTELUKASTActive
Quantity: 5 mg in 1 1
Code: MHM278SD3E
Classification: ACTIB