FDA.reportPublic FDA data

VENOFER (IRON SUCROSE)

Product NDC
51662-1568
11-digit product format
516621568
Labeler code
51662
Product ID
51662-1568_1677c959-a5e5-8d41-e063-6294a90a4ebe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENOFER (IRON SUCROSE)
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA021135
Marketing category
NDA
Marketing start
2021-06-25
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 (IRON SUCROSE)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRON SUCROSE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiFZ7NYF5N8L
Rxcui1741267

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
51662-1568-1VENOFER (IRON SUCROSE)5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION52
51662-1568-2VENOFER (IRON SUCROSE)1 in 1 POUCHINJECTION, SOLUTION12
51662-1568-3VENOFER (IRON SUCROSE)10 in 1 CASEINJECTION, SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1568VENOFER (IRON SUCROSE) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]2Current NDC, Legacy NDC, 3 package rows20240420_c59cb54c-bee5-96d6-e053-2995a90a767c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741267iron (as iron sucrose) 100 MG in 5 ML InjectionPSNc59cb54c-bee5-96d6-e053-2995a90a767c2
17412675 ML iron sucrose 20 MG/ML InjectionSCDc59cb54c-bee5-96d6-e053-2995a90a767c2
1741267ferric oxide, saccharated 100 MG per 5 ML InjectionSYc59cb54c-bee5-96d6-e053-2995a90a767c2
1741267iron (as iron sucrose) 100 MG per 5 ML InjectionSYc59cb54c-bee5-96d6-e053-2995a90a767c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1568-1516621568015 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1) 5 ml2021-06-250000-00-00NoNoCurrent
51662-1568-2516621568021 in 1 POUCHHistorical
51662-1568-35166215680310 POUCH in 1 CASE (51662-1568-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1568-2) / 5 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1) 10 pouch2021-06-25NoNoCurrent