Itraconazole
Itraconazole Capsules (100 mg) Rx Only
Approved
Approval ID
68165d90-953c-e2f5-e053-2a91aa0ada25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
AvPAK
DUNS: 832926666
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Itraconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50268-450
Application NumberANDA205080
Product Classification
M
Marketing Category
C73584
G
Generic Name
Itraconazole
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (16)
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROSEInactive
Code: IY9XDZ35W2
Classification: IACT
ITRACONAZOLEActive
Quantity: 100 mg in 1 1
Code: 304NUG5GF4
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT