Varibar Pudding
These highlights do not include all the information needed to use VARIBAR PUDDING safely and effectively. See full prescribing information for VARIBAR PUDDING.VARIBAR PUDDING (barium sulfate) oral paste Initial U.S. Approval: 2016
Approved
Approval ID
553285e2-d0e9-8b7b-4766-a0a6b9496f87
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 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 Code32909-125
Application NumberNDA208844
Product Classification
M
Marketing Category
C73594
G
Generic Name
Barium Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 15, 2018
FDA Product Classification
INGREDIENTS (16)
Barium SulfateActive
Quantity: 400 mg in 1 mL
Code: 25BB7EKE2E
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
DIMETHICONE 1000Inactive
Code: MCU2324216
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ETHYL VANILLINInactive
Code: YC9ST449YJ
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT