FDA.reportPublic FDA data

NDC 71719-2040 - Vizumax ENEM

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71719-2040
Package NDCs from labels
71719-2040-1, 71719-2040-2
Manufacturer
Vizumax Diagnostics LLC
Effective date
2021-10-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vizumax ENEM - Vizumax Diagnostics LLCVizumax Diagnostics LLC2021-10-04HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71719-2040-12022-07-29These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.
71719-2040-22022-07-29These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.
71719-2040-12021-10-04These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.
71719-2040-22021-10-04These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.
71719-2040-12021-01-29These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.
71719-2040-22021-01-29These highlights do not include all the information needed to use, see full prescribing information for additional details. Initial U.S. Approval.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71719-2040-1Vizumax ENEM454 g in 1 BAGPOWDER, FOR SUSPENSION4544
71719-2040-2Vizumax ENEM397 g in 1 BAGPOWDER, FOR SUSPENSION3974

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71719-2040VIZUMAX ENEM (BARIUM SULFATE) POWDER, FOR SUSPENSION [VIZUMAX DIAGNOSTICS LLC]42 package rows20211005_2a9517f0-533c-4a22-88ab-e0aa5fd57b4d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 8 · 145 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH PLUSCARBOXYMETHYLCELLULOSE SODIUMAllergan, Inc.0f6a4b4b-cde6-4518-84b5-ce997f1154a72022-06-28WarningsExact identifier
unii: K679OBS311
AddiclenzBETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.e39235ea-2a2f-44a7-92d6-fb1d428ebabd2022-05-12WarningsExact identifier
unii: 1Q73Q2JULR
ACD-AANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA AFenwal, Inc.22805f0d-ba58-41ea-b245-19980abcda222022-02-11Exact identifier
unii: 1Q73Q2JULR
cd86fd02-3d56-1747-e053-2995a90a66af2a9517f0-533c-4a22-88ab-e0aa5fd57b4d2021-10-04Warnings, Adverse reactionsExact identifier
spl id: cd86fd02-3d56-1747-e053-2995a90a66af
spl set id: 2a9517f0-533c-4a22-88ab-e0aa5fd57b4d
AdditoxTRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMBioActive Nutritional, Inc.319ee2fe-58e3-495e-bf0d-df201f6fbb1c2018-07-18WarningsExact identifier
unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.