MD GASTROVIEW
August 2017 MD-Gastroview (Diatrizoate Meglumine and Diatrizoate Sodium Solution USP)
Approved
Approval ID
b348b1cf-6250-4ab6-b2bf-3bff86628c53
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Liebel-Flarsheim Company LLC
DUNS: 057880002
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diatrizoate meglumine and diatrizoate sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0019-4816
Application NumberANDA087388
Product Classification
M
Marketing Category
C73584
G
Generic Name
diatrizoate meglumine and diatrizoate sodium
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateFebruary 15, 2017
FDA Product Classification
INGREDIENTS (7)
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIATRIZOATE SODIUMActive
Quantity: 100 mg in 1 mL
Code: V5403H8VG7
Classification: ACTIB
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DIATRIZOATE MEGLUMINEActive
Quantity: 600 mg in 1 mL
Code: 3X9MR4N98U
Classification: ACTIB