Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Pfizer Inc
113480771
Manufacturing Establishments3
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Pfizer Ireland Pharmaceuticals
Roerig
Pfizer Inc
985052076
Pfizer Laboratories Div Pfizer Inc
Roerig
Pfizer Inc
001147495
Pfizer Manufacturing Deutschland GmbH
Roerig
Pfizer Inc
341970073
Products6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diflucan
Product Details
NDC Product Code
0049-3420Application Number
NDA019949Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 7, 2024FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 100 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Diflucan
Product Details
NDC Product Code
0049-3500Application Number
NDA019949Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 7, 2024FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 150 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Diflucan
Product Details
NDC Product Code
0049-3410Application Number
NDA019949Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 7, 2024MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 50 mg in 1 1
Diflucan
Product Details
NDC Product Code
0049-3440Application Number
NDA020090Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 7, 2024XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 350 mg in 35 mL
SUCROSEInactive
Code: C151H8M554Class: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
Diflucan
Product Details
NDC Product Code
0049-3430Application Number
NDA019949Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 7, 2024FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 200 mg in 1 1
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
Diflucan
Product Details
NDC Product Code
0049-3450Application Number
NDA020090Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
March 7, 2024FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 1400 mg in 35 mL
SUCROSEInactive
Code: C151H8M554Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT