E-Z-Paque
These highlights do not include all the information needed to use Liquid E-Z-PAQUE safely and effectively. See full prescribing information for Liquid E-Z-PAQUE. Liquid E-Z-PAQUE (barium sulfate) oral suspensionInitial U.S. Approval: 2016
Approved
Approval ID
2ecea1ab-66c8-4eb0-8503-6d6b41b51328
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2020
Manufacturers
FDA
E-Z-EM Canada Inc
DUNS: 204211163
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
barium sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code32909-186
Application NumberNDA208143
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2020
FDA Product Classification
INGREDIENTS (14)
Barium SulfateActive
Quantity: 0.6 g in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
barium sulfate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code32909-187
Application NumberNDA208143
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2020
FDA Product Classification
INGREDIENTS (14)
Barium SulfateActive
Quantity: 0.6 g in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT