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ENTERO Vu 24%

These highlights do not include all the information needed to use ENTERO VU 24% safely and effectively. See full prescribing information for ENTERO VU 24%. ENTERO VU 24% (barium sulfate) oral suspension Initial U.S. Approval: 2016

Approved
Approval ID

83a06a8e-93db-a59b-933c-5882127bce7c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2022

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 Code32909-145
Application NumberNDA208143
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2020
FDA Product Classification

INGREDIENTS (17)

BARIUM SULFATEActive
Quantity: 240 mg in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
CARRAGEENAN SODIUMInactive
Code: 7CY8BVL34N
Classification: IACT
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

barium sulfate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code32909-146
Application NumberNDA208143
Product Classification
M
Marketing Category
C73594
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 7, 2020
FDA Product Classification

INGREDIENTS (17)

BARIUM SULFATEActive
Quantity: 240 mg in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CARRAGEENAN SODIUMInactive
Code: 7CY8BVL34N
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216
Classification: IACT
METHYLCELLULOSE (400 MPA.S)Inactive
Code: O0GN6F9B2Y
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT

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ENTERO Vu 24% - FDA Drug Approval Details