itraconazole
Itraconazole Capsules, USP
Approved
Approval ID
57ee8148-e958-4732-9843-3b9c15bd4b8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
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 Code68382-697
Application NumberANDA204672
Product Classification
M
Marketing Category
C73584
G
Generic Name
itraconazole
Product Specifications
Route of AdministrationORAL
Effective DateNovember 10, 2022
FDA Product Classification
INGREDIENTS (19)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ITRACONAZOLEActive
Quantity: 100 mg in 1 1
Code: 304NUG5GF4
Classification: ACTIB
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8
Classification: IACT