Itraconazole Oral
Itraconazole Oral Solution
Approved
Approval ID
da63870d-b426-4e49-9591-5bb51f962e66
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2023
Manufacturers
FDA
Natco Pharma USA LLC
DUNS: 079590418
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 Code69339-159
Application NumberANDA212239
Product Classification
M
Marketing Category
C73584
G
Generic Name
Itraconazole
Product Specifications
Route of AdministrationORAL
Effective DateApril 11, 2022
FDA Product Classification
INGREDIENTS (8)
ascorbic acidInactive
Code: PQ6CK8PD0R
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
ItraconazoleActive
Quantity: 10 mg in 1 mL
Code: 304NUG5GF4
Classification: ACTIB
waterInactive
Code: 059QF0KO0R
Classification: IACT
noncrystallizing sorbitol solutionInactive
Code: 9E0S3UM200
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT