OMNISCAN
These highlights do not include all the information needed to use OMNISCAN safely and effectively. See full prescribing information for OMNISCAN. OMNISCAN™ (gadodiamide) Injection for Intravenous Use Initial U.S. Approval: 1993
Approved
Approval ID
d539c8b2-13fe-4ba2-994e-b4d0ee1ef490
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2024
Manufacturers
FDA
GE Healthcare Inc.
DUNS: 053046579
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
gadodiamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0407-0690
Application NumberNDA020123
Product Classification
M
Marketing Category
C73594
G
Generic Name
gadodiamide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 25, 2018
FDA Product Classification
INGREDIENTS (4)
gadodiamideActive
Quantity: 287 mg in 1 mL
Code: 84F6U3J2R6
Classification: ACTIB
caldiamide sodiumInactive
Quantity: 12 mg in 1 mL
Code: 1M6415C70M
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT