iopamidol
Iopamidol Injection, USP, 41%
Approved
Approval ID
69e9ab05-88f8-45f9-8bc1-ed33ab1385f0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 10, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iopamidol
PRODUCT DETAILS
NDC Product Code70436-211
Application NumberANDA217134
Marketing CategoryC73584
Route of AdministrationINTRAVASCULAR
Effective DateOctober 10, 2023
Generic Nameiopamidol
INGREDIENTS (4)
TROMETHAMINEInactive
Quantity: 1 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Quantity: 0.26 mg in 1 mL
Code: 25IH6R4SGF
Classification: IACT
IOPAMIDOLActive
Quantity: 408 mg in 1 mL
Code: JR13W81H44
Classification: ACTIB