Cystografin Dilute
CYSTOGRAFIN DILUTE Diatrizoate Meglumine Injection USP 18%
Approved
Approval ID
e56882fa-4a30-43b1-bb6b-f7d4a4101c4e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 2, 2018
Manufacturers
FDA
BRACCO DIAGNOSTICS INC
DUNS: 849234661
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diatrizoate meglumine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0270-1410
Application NumberNDA010040
Product Classification
M
Marketing Category
C73594
G
Generic Name
diatrizoate meglumine
Product Specifications
Route of AdministrationINTRAVESICAL
Effective DateOctober 2, 2018
FDA Product Classification
INGREDIENTS (2)
edetate disodiumInactive
Quantity: 0.4 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
diatrizoate meglumineActive
Quantity: 180 mg in 1 mL
Code: 3X9MR4N98U
Classification: ACTIB