E-Z-Paque
These highlights do not include all the information needed to use E-Z-PAQUE safely and effectively. See full prescribing information for E-Z-PAQUE. E-Z-PAQUE (barium sulfate) for oral suspensionInitial U.S. Approval: 2016
Approved
Approval ID
7225868a-4037-c96a-44e3-3326d36cbedc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
Manufacturers
FDA
E-Z-EM Canada Inc
DUNS: 204211163
Products 1
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 Code32909-750
Application NumberNDA208036
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateApril 13, 2017
FDA Product Classification
INGREDIENTS (13)
Barium SulfateActive
Quantity: 960 mg in 1 g
Code: 25BB7EKE2E
Classification: ACTIB
anhydrous citric acidInactive
Code: XF417D3PSL
Classification: IACT
dimethicone 1000Inactive
Code: MCU2324216
Classification: IACT
pectinInactive
Code: 89NA02M4RX
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
tragacanthInactive
Code: 2944357O2O
Classification: IACT
carrageenan sodiumInactive
Code: 7CY8BVL34N
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT