Itraconazole
Rx Only
Approved
Approval ID
8d34a00f-f6f9-4bd5-9cba-505038d15c46
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2023
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
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 Code49884-239
Application NumberANDA205724
Product Classification
M
Marketing Category
C73584
G
Generic Name
Itraconazole
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2023
FDA Product Classification
INGREDIENTS (10)
ITRACONAZOLEActive
Quantity: 100 mg in 1 1
Code: 304NUG5GF4
Classification: ACTIB
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT