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
NDC Product Code68001-254
Application NumberANDA077253
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic NameFluconazole
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
NDC Product Code68001-251
Application NumberANDA077253
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic NameFluconazole
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
NDC Product Code68001-253
Application NumberANDA077253
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic NameFluconazole
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
NDC Product Code68001-252
Application NumberANDA077253
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2023
Generic NameFluconazole
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