Zafirlukast
Zafirlukast Tablets
Approved
Approval ID
5d30ffab-38a1-411d-94ad-0a15c227d882
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2020
Manufacturers
FDA
Camber Pharmaceuticals, Inc.
DUNS: 826774775
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 Code31722-008
Application NumberANDA212475
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2020
FDA Product Classification
INGREDIENTS (8)
ZAFIRLUKASTActive
Quantity: 20 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Zafirlukast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-007
Application NumberANDA212475
Product Classification
M
Marketing Category
C73584
G
Generic Name
Zafirlukast
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 17, 2020
FDA Product Classification
INGREDIENTS (8)
ZAFIRLUKASTActive
Quantity: 10 mg in 1 1
Code: XZ629S5L50
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT