Diflucan
DIFLUCAN (Fluconazole in Dextrose Injection and Fluconazole in Sodium Chloride Injection, for intravenous use)
Approved
Approval ID
ff5f3ea4-42e2-4e8b-a594-a3964d2016ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 7, 2024
Manufacturers
FDA
Roerig
DUNS: 829076996
Products 6
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 Code0049-3420
Application NumberNDA019949
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2024
FDA Product Classification
INGREDIENTS (8)
FLUCONAZOLEActive
Quantity: 100 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
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 Code0049-3500
Application NumberNDA019949
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2024
FDA Product Classification
INGREDIENTS (8)
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-3410
Application NumberNDA019949
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2024
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FLUCONAZOLEActive
Quantity: 50 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-3440
Application NumberNDA020090
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2024
FDA Product Classification
INGREDIENTS (8)
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FLUCONAZOLEActive
Quantity: 350 mg in 35 mL
Code: 8VZV102JFY
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-3430
Application NumberNDA019949
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2024
FDA Product Classification
INGREDIENTS (8)
FLUCONAZOLEActive
Quantity: 200 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
fluconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0049-3450
Application NumberNDA020090
Product Classification
M
Marketing Category
C73594
G
Generic Name
fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateMarch 7, 2024
FDA Product Classification
INGREDIENTS (8)
FLUCONAZOLEActive
Quantity: 1400 mg in 35 mL
Code: 8VZV102JFY
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT