Fluconazole
Fluconazole Tablets
Approved
Approval ID
83bcb8fc-53f1-4d7b-b083-0905b52c6c7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-254
Application NumberANDA077253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FLUCONAZOLEActive
Quantity: 200 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-251
Application NumberANDA077253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FLUCONAZOLEActive
Quantity: 50 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-253
Application NumberANDA077253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
Fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-252
Application NumberANDA077253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (6)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FLUCONAZOLEActive
Quantity: 100 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB