IRON DEXTRAN

Product NDC
51662-1441
11-digit product format
516621441
Labeler code
51662
Product ID
51662-1441_2b3948f4-fdef-5321-e063-6394a90ad70c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IRON DEXTRAN
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
NDA017441
Marketing category
NDA
Marketing start
2019-12-22
Substance
IRON DEXTRAN
Active strength
50 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
IRON DEXTRAN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRON DEXTRAN50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii95HR524N2M
Rxcui311144

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
51662-1441-1IRON DEXTRAN2 mL in 1 VIAL, SINGLE-DOSEINJECTION23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1441IRON DEXTRAN INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20250110_9a4cd424-865d-fdd1-e053-2995a90a00ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311144iron dextran 100 MG in 2 ML InjectionPSN9a4cd424-865d-fdd1-e053-2995a90a00ff3
3111442 ML iron-dextran complex 50 MG/ML InjectionSCD9a4cd424-865d-fdd1-e053-2995a90a00ff3
311144iron dextran (as iron) 100 MG per 2 ML InjectionSY9a4cd424-865d-fdd1-e053-2995a90a00ff3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1441-1516621441012 mL in 1 VIAL, SINGLE-DOSE (51662-1441-1) 2 ml2019-12-220000-00-00NoNoCurrent