Itraconazole
Itraconazole Capsules Rx only
Approved
Approval ID
3c0843c1-03bb-404d-b539-8680db50a452
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 2, 2023
Manufacturers
FDA
Accord Healthcare Inc.
DUNS: 604222237
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 Code16729-271
Application NumberANDA205991
Product Classification
M
Marketing Category
C73584
G
Generic Name
ITRACONAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 2, 2023
FDA Product Classification
INGREDIENTS (11)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
POLYETHYLENE GLYCOL 20000Inactive
Code: 5WKN5KL2O8
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ITRACONAZOLEActive
Quantity: 100 mg in 1 1
Code: 304NUG5GF4
Classification: ACTIB
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT