Ferumoxytol

Product NDC: 0781-3154
11-digit product format: 007813154
Labeler code: 0781
Product ID: 0781-3154_7374e3ff-0761-45f0-bb76-bf1b74a20480
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ferumoxytol
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Sandoz Inc
Application: ANDA206604
Marketing category: ANDA
Marketing start: 2021-07-15
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A206604-001	FERUMOXYTOL	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB		2021-01-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A206604-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206604-001	FERUMOXYTOL	EQ 510MG IRON/17ML (EQ 30MG IRON/ML)	SOLUTION / INTRAVENOUS	AB	2021-01-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A206604-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206604-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206604-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206604-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206604-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206604-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206604-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206604-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206604-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206604-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206604-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206604-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206604-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206604-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206604-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206604-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206604-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206604-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A206604-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206604-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206604-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206604-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206604-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206604-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206604-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206604-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206604-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206604-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206604-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206604-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206604-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206604-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206604-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206604-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A206604-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A206604-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE	510 mg/17mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CLH5FT6412	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860605	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
cf94c7fc-13a0-4ac9-bb85-9c38aa704d35	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0781-3154-01	2023-08-02	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-01	2023-08-02	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-95	2023-08-02	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-95	2023-08-02	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-01	2023-07-28	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-01	2023-07-28	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-95	2023-07-28	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009
0781-3154-95	2023-07-28	These highlights do not include all the information needed to use FERUMOXYTOL INJECTION safely and effectively. See full prescribing information for FERUMOXYTOL INJECTION. FERUMOXYTOL injection, for intravenous use Initial U.S. Approval: 2009

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0781-3154-01	Ferumoxytol	1 in 1 CARTON	INJECTION	1	6
0781-3154-01	Ferumoxytol	17 mL in 1 VIAL, SINGLE-DOSE	INJECTION	17	6
0781-3154-95	Ferumoxytol	10 in 1 CARTON	INJECTION	10	6
0781-3154-95	Ferumoxytol	17 mL in 1 VIAL, SINGLE-DOSE	INJECTION	17	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-3154-01	ML - Milliliter	0781-3154	519a55f6-ffd6-44e2-a582-fef667997ae1	1	2021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-3154	FERUMOXYTOL INJECTION [SANDOZ INC]	5	Current NDC, Legacy NDC, 4 package rows	20230803_cf94c7fc-13a0-4ac9-bb85-9c38aa704d35.zip

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
Ferumoxytol	FERUMOXYTOL	Sandoz Inc	cf94c7fc-13a0-4ac9-bb85-9c38aa704d35	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206604 application number: ANDA206604 ndc (product): 0781-3154

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
CLH5FT6412	FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE	FERUMOXYTOL NON-STOICHIOMETRIC MAGNETITE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860605	iron (as ferumoxytol) 510 MG in 17 ML Injection	PSN	cf94c7fc-13a0-4ac9-bb85-9c38aa704d35	6
860605	17 ML ferumoxytol 30 MG/ML Injection	SCD	cf94c7fc-13a0-4ac9-bb85-9c38aa704d35	6
860605	iron (as ferumoxytol) 510 MG per 17 ML Injection	SY	cf94c7fc-13a0-4ac9-bb85-9c38aa704d35	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-3154-01	00781315401	1 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-01) / 17 mL in 1 VIAL, SINGLE-DOSE	2021-07-15	0000-00-00	No	No	Current
0781-3154-95	00781315495	10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3154-95) / 17 mL in 1 VIAL, SINGLE-DOSE	2021-07-15	0000-00-00	No	No	Current