FDA.reportPublic FDA data

Venofer

Product NDC
49230-530
11-digit product format
492300530
Labeler code
49230
Product ID
49230-530_e12cb876-ae80-416b-9bd3-a1cc83c9e666
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
iron sucrose
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Medical Care Holdings, Inc.
Application
NDA021135
Marketing category
NDA
Marketing start
2011-01-27
Substance
IRON SUCROSE
Active strength
20 mg/mL
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venofer
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRON SUCROSE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFZ7NYF5N8L
Rxcui1741267, 1741268, 1741270, 1741271

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49230-530-01Venofer2.5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION2.529
49230-530-10Venofer10 in 1 BOXINJECTION, SOLUTION1029
49230-530-25Venofer25 in 1 TRAYINJECTION, SOLUTION2529

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49230-530-10ML - Milliliter49230-530641edeb5-d02d-4ede-a33e-399e2e03764912012-07-24
49230-530-25ML - Milliliter49230-5300be0ff77-08da-42a6-9f9c-dde61182f66b12014-09-03

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49230-530VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE HOLDINGS, INC.]28Current NDC, Legacy NDC, 3 package rows20241121_f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741267iron (as iron sucrose) 100 MG in 5 ML InjectionPSNf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741270iron (as iron sucrose) 50 MG in 2.5 mL InjectionPSNf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741268Venofer (iron) 100 MG in 5 mL InjectionPSNf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741271Venofer (iron) 50 MG in 2.5 mL InjectionPSNf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
17412712.5 ML iron sucrose 20 MG/ML Injection [Venofer]SBDf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
17412685 ML iron sucrose 20 MG/ML Injection [Venofer]SBDf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
17412702.5 ML iron sucrose 20 MG/ML InjectionSCDf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
17412675 ML iron sucrose 20 MG/ML InjectionSCDf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
17412712.5 ML Venofer 20 MG/ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
17412685 ML Venofer 20 MG/ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741267ferric oxide, saccharated 100 MG per 5 ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741270ferric oxide, saccharated 50 MG per 2.5 ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741267iron (as iron sucrose) 100 MG per 5 ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741270iron (as iron sucrose) 50 MG per 2.5 ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741268Venofer (iron) 100 MG per 5 ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029
1741271Venofer 50 MG per 2.5 ML InjectionSYf1ab1a22-2b99-4d27-8b5a-9c3bcd5e304029

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49230-530-01492300530012.5 mL in 1 VIAL, SINGLE-DOSE2.5 mlHistorical
49230-530-104923005301010 VIAL, SINGLE-DOSE in 1 BOX (49230-530-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01) 2011-01-270000-00-00NoNoCurrent
49230-530-254923005302525 VIAL, SINGLE-DOSE in 1 TRAY (49230-530-25) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01) 2011-01-270000-00-00NoNoCurrent