Vizumax ENEM
These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.
Approved
Approval ID
2a9517f0-533c-4a22-88ab-e0aa5fd57b4d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2021
Manufacturers
FDA
Vizumax Diagnostics LLC
DUNS: 080352473
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 Code71719-2040
Product Classification
G
Generic Name
barium sulfate
Product Specifications
Route of AdministrationRECTAL
Effective DateOctober 4, 2021
FDA Product Classification
INGREDIENTS (7)
SACCHARIN SODIUM ANHYDROUSInactive
Code: I4807BK602
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SODIUM DEHYDROACETATEInactive
Code: 8W46YN971G
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT
BARIUM SULFATEActive
Quantity: 960 mg in 1 g
Code: 25BB7EKE2E
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT