FDA.reportPublic FDA data

NDC 49230-534-01 - Venofer

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
49230-534
Requested NDC
49230-534-01
Package NDCs from labels
49230-534-01, 49230-534-10, 49230-534-25
Manufacturer
Fresenius Medical Care Holdings, Inc. | American Regent, Inc. | Vifor (International) Inc.
Effective date
2022-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VenoferFresenius Medical Care Holdings, Inc. | American Regent, Inc. | Vifor (International) Inc.2022-06-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49230-534-01Venofer5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION529
49230-534-10Venofer10 in 1 BOXINJECTION, SOLUTION1029
49230-534-25Venofer25 in 1 TRAYINJECTION, SOLUTION2529

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49230-534VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE HOLDINGS, INC.]28Current NDC, Legacy NDC, 3 package rows20241121_f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49230-534-10ML - Milliliter49230-53456639a4a-2bb0-4ee5-8ca8-0bf68fdee0b012012-07-24
49230-534-25ML - Milliliter49230-534b2de4006-2fd9-49bd-96c4-3a81fe7b28bd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRON SUCROSEACTIVE INGREDIENTFZ7NYF5N8LVENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]9
FERRIC CATIONACTIVE MOIETY91O4LML611VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]9
WATERINACTIVE INGREDIENT059QF0KO0RVENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE NORTH AMERICA]9

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 9 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERAsclemed USA, Inc.45c38269-883c-4198-a9d5-03810a4420ec2021-01-14Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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