iopamidol
Iopamidol Injection, USP, 41% and Iopamidol Injection, USP, 61%
Approved
Approval ID
0b9e0d24-c6ca-4e22-9422-936e9d475eaa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals
DUNS: 039452765
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iopamidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-124
Application NumberANDA215382
Product Classification
M
Marketing Category
C73584
G
Generic Name
iopamidol
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (4)
TROMETHAMINEInactive
Quantity: 1 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.26 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IOPAMIDOLActive
Quantity: 408 mg in 1 mL
Code: JR13W81H44
Classification: ACTIB
iopamidol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-126
Application NumberANDA215382
Product Classification
M
Marketing Category
C73584
G
Generic Name
iopamidol
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (4)
TROMETHAMINEInactive
Quantity: 1 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.39 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
IOPAMIDOLActive
Quantity: 612 mg in 1 mL
Code: JR13W81H44
Classification: ACTIB