Diatrizoate Meglumine and Diatrizoate Sodium
Diatrizoate Meglumine and Diatrizoate Sodium Solution USP
Approved
Approval ID
e9da4d3d-d0ca-44f7-aaeb-ae49c3839775
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 22, 2020
Manufacturers
FDA
Guardian Drug Company
DUNS: 119210276
Products 2
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 Code53041-688
Application NumberANDA214201
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diatrizoate Meglumine and Diatrizoate Sodium
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (11)
DIATRIZOATE SODIUMActive
Quantity: 100 mg in 1 mL
Code: V5403H8VG7
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIATRIZOATE MEGLUMINEActive
Quantity: 660 mg in 1 mL
Code: 3X9MR4N98U
Classification: ACTIB
Diatrizoate Meglumine and Diatrizoate Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53041-690
Application NumberANDA214201
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diatrizoate Meglumine and Diatrizoate Sodium
Product Specifications
Route of AdministrationORAL, RECTAL
Effective DateDecember 18, 2020
FDA Product Classification
INGREDIENTS (11)
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
DIATRIZOATE SODIUMActive
Quantity: 100 mg in 1 mL
Code: V5403H8VG7
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
DIATRIZOATE MEGLUMINEActive
Quantity: 660 mg in 1 mL
Code: 3X9MR4N98U
Classification: ACTIB