FDA.reportPublic FDA data

NDC 52919-002 - pentetate zinc trisodium

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
52919-002
Package NDCs from labels
52919-002-03
Manufacturer
Hameln Pharmaceuticals
Effective date
2006-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
pentetate zinc trisodium - Hameln PharmaceuticalsHameln Pharmaceuticals2006-12-18HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52919-002-03pentetate zinc trisodium10 in 1 PACKAGEINJECTION, SOLUTION, CONCENTRATE101
52919-002-03pentetate zinc trisodium5 mL in 1 AMPULEINJECTION, SOLUTION, CONCENTRATE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52919-002PENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM) INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMACEUTICALS]12 package rows20070105_9FCA10EE-973E-4FE0-AAF5-A0416918A397.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52919-002-03ML - Milliliter52919-002fa40ff36-a87a-440a-ad22-1a44c192904a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pentetate zinc trisodiumACTIVE INGREDIENTNXU65IC8PGPENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM) INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMACEUTICALS]1
pentetic acidACTIVE MOIETY7A314HQM0IPENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM) INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMACEUTICALS]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IPENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM) INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMACEUTICALS]1
waterINACTIVE INGREDIENT059QF0KO0RPENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM) INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMACEUTICALS]1
zinc oxideINACTIVE INGREDIENTSOI2LOH54ZPENTETATE ZINC TRISODIUM (PENTETATE ZINC TRISODIUM) INJECTION, SOLUTION, CONCENTRATE [HAMELN PHARMACEUTICALS]1

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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9FCA10EE-973E-4FE0-AAF5-A0416918A3979FCA10EE-973E-4FE0-AAF5-A0416918A3972006-12-18Warnings, Adverse reactionsExact identifier
spl id: 9FCA10EE-973E-4FE0-AAF5-A0416918A397
spl set id: 9FCA10EE-973E-4FE0-AAF5-A0416918A397

Reported adverse events (FAERS/openFDA)#

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