FDA.reportPublic FDA data

Feraheme

Product NDC
59338-775
11-digit product format
593380775
Labeler code
59338
Product ID
59338-775_69a91fd4-deed-452e-b700-ea68b6e85421
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ferumoxytol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
AMAG Pharmaceuticals, Inc.
Application
NDA022180
Marketing category
NDA
Marketing start
2009-07-13
Substance
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE
Active strength
510 mg/17mL
Pharmacologic classes
Iron [CS], Parenteral Iron Replacement [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Feraheme
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE510 mg/17mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCLH5FT6412
Rxcui860605, 1191357

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59338-775-01Feraheme1 in 1 CARTONINJECTION122
59338-775-01Feraheme17 mL in 1 VIAL, SINGLE-USEINJECTION1722
59338-775-10Feraheme17 mL in 1 VIAL, SINGLE-USEINJECTION1722
59338-775-10Feraheme10 in 1 CARTONINJECTION1022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59338-775-01ML - Milliliter59338-775aa4ba219-e9cd-4b56-9dab-ba55c5c25dd112012-07-24
59338-775-10ML - Milliliter59338-7756cb023de-c758-41eb-9862-cd26fca43bb012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEACTIVE INGREDIENTCLH5FT6412FERAHEME (FERUMOXYTOL) INJECTION [AMAG PHARMACEUTICALS, INC.]13
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITEACTIVE MOIETYCLH5FT6412FERAHEME (FERUMOXYTOL) INJECTION [AMAG PHARMACEUTICALS, INC.]13
MANNITOLINACTIVE INGREDIENT3OWL53L36AFERAHEME (FERUMOXYTOL) INJECTION [AMAG PHARMACEUTICALS, INC.]13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59338-775FERAHEME (FERUMOXYTOL) INJECTION [AMAG PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 4 package rows20230512_32b0e320-a739-11dc-a704-0002a5d5c51b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59338-775-01593380775011 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE2009-07-130000-00-00NoNoCurrent
59338-775-105933807751010 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE2009-07-130000-00-00NoNoCurrent