NDC Code(s) : 32909-804-01
Packager : E-Z-EM Canada Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Polibar ACBBarium Sulfate POWDER, FOR SUSPENSION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:32909-804
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BARIUM SULFATE(UNII: 25BB7EKE2E)
(BARIUM SULFATE - UNII:25BB7EKE2E) 		BARIUM SULFATE965 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE 1000(UNII: MCU2324216)
PECTIN(UNII: 89NA02M4RX)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SORBITOL(UNII: 506T60A25R)
TRAGACANTH(UNII: 2944357O2O)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:32909-804-01397 g in 1 BAG Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/15/1978

PRINCIPAL DISPLAY PANEL

POLIBAR® ACB Barium Sulfate 96% w/w
Prefilled Disposable Barium Enema Kit
NDC:32909-804-01

POLIBAR® ACB panelPOLIBAR® ACB panel