FeraBright

Product NDC: 24338-310
11-digit product format: 243380310
Labeler code: 24338
Product ID: 24338-310_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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219868-001	FERABRIGHT	FERUMOXYTOL	EQ 300MG IRON/10ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-10-16
N219868-002	FERABRIGHT	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS		RLD, RS	2025-10-16

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219868-001	NP	2028-10-16
N219868-002	NP	2028-10-16

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219868-001	FERABRIGHT	EQ 300MG IRON/10ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219868-002	FERABRIGHT	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219868-001	FERABRIGHT	EQ 300MG IRON/10ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219868-002	FERABRIGHT	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-16	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219868-001	FERABRIGHT	EQ 300MG IRON/10ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219868-002	FERABRIGHT	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-10-16	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219868-001	NP	2028-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219868-002	NP	2028-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219868-001	NP	2028-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219868-002	NP	2028-10-16	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219868-001	NP	2028-10-16	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219868-002	NP	2028-10-16	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERUMOXYTOL	30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R8DG7T2D3A	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ac666008-a14f-43b4-9d06-ec70f45a4234	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
910c1bd7-67d1-44c7-ad4f-9445f827edcc	Product name	1	20230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
24338-310-10	FeraBright	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION	10		2
24338-310-10	FeraBright	1 in 1 CARTON	INJECTION	1		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24338-310-10	ML - Milliliter	24338-310	e4413687-1b61-4ff8-8744-ad65fbd5e275	1	2026-03-17

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FeraBright	FERUMOXYTOL	Azurity Pharmaceuticals, Inc.	ac666008-a14f-43b4-9d06-ec70f45a4234	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219868 application number: NDA219868 ndc (product): 24338-310

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
24338-310-10	24338031010	1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10) / 10 mL in 1 VIAL, SINGLE-DOSE	2025-10-20	No	No	Current