Zafirlukast
Zafirlukast Tablets
Approved
Approval ID
0262e192-94f4-423d-a58e-bb374dc106fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 25, 2018
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
zafirlukast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-549
Application NumberNDA020547
Product Classification
M
Marketing Category
C73594
G
Generic Name
zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (8)
ZAFIRLUKASTActive
Quantity: 10 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
zafirlukast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code49884-554
Application NumberNDA020547
Product Classification
M
Marketing Category
C73594
G
Generic Name
zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2022
FDA Product Classification
INGREDIENTS (8)
ZAFIRLUKASTActive
Quantity: 20 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT