FLUCONAZOLE
FLUCONAZOLE TABLETS, USP 50 mg, 100 mg, 150 mg and 200 mg Rx Only
Approved
Approval ID
f86ea347-78f5-43b8-9574-a52569a4237b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-130
Application NumberANDA076665
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUCONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FLUCONAZOLEActive
Quantity: 50 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FLUCONAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-133
Application NumberANDA076665
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUCONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
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 Code62135-131
Application NumberANDA076665
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUCONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FLUCONAZOLEActive
Quantity: 100 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FLUCONAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-132
Application NumberANDA076665
Product Classification
M
Marketing Category
C73584
G
Generic Name
FLUCONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 11, 2023
FDA Product Classification
INGREDIENTS (6)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT