Fluconazole
Fluconazole Tablets
Approved
Approval ID
c89c3bbd-1170-4170-e053-2a95a90a8e41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 6, 2023
Manufacturers
FDA
St. Mary's Medical Park Pharmacy
DUNS: 063050751
Products 1
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 Code60760-803
Application NumberANDA077253
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fluconazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2023
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB