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FLUCONAZOLE

FLUCONAZOLE

Approved
Approval ID

f70c14ff-4bdc-4c1f-a118-ff3e85a04302

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 25, 2015

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

FLUCONAZOLE

PRODUCT DETAILS

NDC Product Code61919-282
Application NumberANDA076077
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 25, 2015
Generic NameFLUCONAZOLE

INGREDIENTS (10)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FLUCONAZOLEActive
Quantity: 150 mg in 1 1
Code: 8VZV102JFY
Classification: ACTIB
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
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FLUCONAZOLE - FDA Approval | MedPath