FeraBright

Product NDC
24338-510
11-digit product format
243380510
Labeler code
24338
Product ID
24338-510_ac5e7507-8e66-4da5-abd9-75ae80369b9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ferumoxytol
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Azurity Pharmaceuticals, Inc.
Application
NDA219868
Marketing category
NDA
Marketing start
2025-10-20
Substance
FERUMOXYTOL
Active strength
30 mg/mL
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
FeraBright
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FERUMOXYTOL30 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR8DG7T2D3A

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24338-510-17FeraBright1 in 1 CARTONINJECTION12
24338-510-17FeraBright17 mL in 1 VIAL, SINGLE-DOSEINJECTION172

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24338-510-17ML - Milliliter24338-510b88849a2-eb6d-41d1-a71d-c2db6a6891a712026-03-17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24338-510-17243380510171 VIAL, SINGLE-DOSE in 1 CARTON (24338-510-17) / 17 mL in 1 VIAL, SINGLE-DOSE2025-10-20NoNoCurrent