Home NDC 59338-775 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 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 N022180-001 FERAHEME FERUMOXYTOL EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022180-001 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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS RLD, RS 2009-06-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022180-001 FERAHEME EQ 510MG IRON/17ML (EQ 30MG IRON/ML) SOLUTION / INTRAVENOUS AB RLD, RS 2009-06-30 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 2 · 54 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022180-001 6599498 2023-06-30 Drug substance, Drug product 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022180-001 6599498 2023-06-30 Drug substance, Drug product 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022180-001 6599498 2023-06-30 Drug substance, Drug product 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022180-001 7553479 2020-03-08 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022180-001 7871597 2020-03-08 Drug substance, Drug product 2011-02-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022180-001 8501158 2020-03-08 U-1422 2013-08-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022180-001 8591864 2020-03-08 Drug product 2013-12-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022180-001 8926947 2020-03-08 Drug substance, Drug product 2015-01-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022180-001 6599498 2023-06-30 Drug substance, Drug product 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022180-001 6599498 2023-06-30 Drug substance, Drug product bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022180-001 6599498 2023-06-30 Drug substance, Drug product 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022180-001 6599498 2023-06-30 Drug substance, Drug product 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022180-001 6599498 2023-06-30 Drug substance, Drug product 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022180-001 7553479 2020-03-08 Drug substance, Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022180-001 7871597 2020-03-08 Drug substance, Drug product 2011-02-15 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022180-001 8501158 2020-03-08 U-1422 2013-08-06 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022180-001 8591864 2020-03-08 Drug product 2013-12-12 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022180-001 8926947 2020-03-08 Drug substance, Drug product 2015-01-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N022180-001 6599498 2023-06-30 Drug substance, Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022180-001 7553479 2020-03-08 Drug substance, Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022180-001 7871597 2020-03-08 Drug substance, Drug product 2011-02-15 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022180-001 8501158 2020-03-08 U-1422 2013-08-06 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022180-001 8591864 2020-03-08 Drug product 2013-12-12 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022180-001 8926947 2020-03-08 Drug substance, Drug product 2015-01-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N022180-001 6599498 2023-06-30 Drug substance, Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022180-001 7553479 2020-03-08 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022180-001 7871597 2020-03-08 Drug substance, Drug product 2011-02-15 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022180-001 8501158 2020-03-08 U-1422 2013-08-06 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022180-001 8591864 2020-03-08 Drug product 2013-12-12 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022180-001 8926947 2020-03-08 Drug substance, Drug product 2015-01-08 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N022180-001 6599498 2023-06-30 Drug substance, Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022180-001 7553479 2020-03-08 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022180-001 7871597 2020-03-08 Drug substance, Drug product 2011-02-15 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022180-001 8501158 2020-03-08 U-1422 2013-08-06 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022180-001 8591864 2020-03-08 Drug product 2013-12-12 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022180-001 8926947 2020-03-08 Drug substance, Drug product 2015-01-08 b00525d2431f…2019-09-15 20:21 UTC 2019-09 N022180-001 6599498 2023-06-30 Drug substance, Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022180-001 7553479 2020-03-08 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022180-001 7871597 2020-03-08 Drug substance, Drug product 2011-02-15 ea99ee380514…2019-07-19 19:46 UTC 2019-07 N022180-001 8501158 2020-03-08 U-1422 2013-08-06 ea99ee380514…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Feraheme
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860605 Internal RxNorm lookup 1191357 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59338-775-01 Feraheme 1 in 1 CARTON INJECTION 1 22 59338-775-01 Feraheme 17 mL in 1 VIAL, SINGLE-USE INJECTION 17 22 59338-775-10 Feraheme 17 mL in 1 VIAL, SINGLE-USE INJECTION 17 22 59338-775-10 Feraheme 10 in 1 CARTON INJECTION 10 22
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59338-775 FERAHEME (FERUMOXYTOL) INJECTION [AMAG PHARMACEUTICALS, INC.] 22 Current NDC, Legacy NDC, 4 package rows 20230512_32b0e320-a739-11dc-a704-0002a5d5c51b.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 Feraheme FERUMOXYTOL AMAG Pharmaceuticals, Inc 32b0e320-a739-11dc-a704-0002a5d5c51b 2026-05-31 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022180 application number: NDA022180 ndc (product): 59338-775
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59338-775-01 59338077501 1 VIAL, SINGLE-USE in 1 CARTON (59338-775-01) / 17 mL in 1 VIAL, SINGLE-USE 2009-07-13 0000-00-00 No No Current 59338-775-10 59338077510 10 VIAL, SINGLE-USE in 1 CARTON (59338-775-10) / 17 mL in 1 VIAL, SINGLE-USE 2009-07-13 0000-00-00 No No Current