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E-Z-Paste

NDC 32909-770-01E-Z-PASTE BARIUM SULFATE ESOPHAGEAL CREAM(60% w/w)

Approved
Approval ID

704132ea-4986-0b2c-2dd4-de89c0282a15

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 29, 2023

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 Code32909-770
Product Classification
G
Generic Name
Barium Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 22, 2018
FDA Product Classification

INGREDIENTS (14)

BARIUM SULFATEActive
Quantity: .6 g in 1 g
Code: 25BB7EKE2E
Classification: ACTIB
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216
Classification: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 7/29/2023

DESCRIPTION

E-Z-PASTE® Barium Sulfate Esophageal Cream (60% w/w) is a barium sulfate cream for oral administration. Each 100 g contains 60 g barium sulfate. Barium sulfate, due to its high molecular density is opaque to x-rays and, therefore, acts as a positive contrast agent for radiographic studies. The active ingredient is barium sulfate and its structural formula is BaSO4. Barium sulfate occurs as a fine, white, odorless, tasteless, bulky powder which is free from grittiness. Its aqueous suspensions are neutral to litmus. It is practically insoluble in water, solutions of acids and alkalies, and organic solvents.

Inactive Ingredients: carboxymethylcellulose sodium, citric acid, ethyl vanillin, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, simethicone emulsion, sodium citrate, and sorbitol solution.

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E-Z-Paste - FDA Drug Approval Details