Corvert
Corvert (ibutilide fumarate) injection
Approved
Approval ID
2428969a-7431-4e94-9503-ad5c680e2ea4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
Pharmacia & Upjohn Company LLC
DUNS: 618054084
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ibutilide fumarate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0009-3794
Application NumberNDA020491
Product Classification
M
Marketing Category
C73594
G
Generic Name
ibutilide fumarate
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (5)
IBUTILIDE FUMARATEActive
Quantity: 0.1 mg in 1 mL
Code: 9L5X4M5L6I
Classification: ACTIB
SODIUM ACETATEInactive
Quantity: 0.189 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 8.9 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT