Desferal

Manufacturer: MITEM PHARMA | Excella GmbH & Co. KG Nürnberger Str. 12 90537 Feucht Germany | Novartis Pharma AG Lichtstrasse 35 CH-4056 Basel Switzerland | SGS International Services Laboratory (ISL) Limited Ringaskiddy Cork, P43 FR 63 Ireland (IRL) | SGS Institut Fresenius GmbH Tegeler Weg 33 10589 Berlin Germany | SGS Institut Fresenius GmbH Im Maisel 14 65232 Taunusstein Germany | Novartis Pharma Stein AG Schaffhauserstrasse 4332 Stein Switzerland | Pharmanalytica SA Via Balestra 6600 Locarno Switzerland | Packaging Coordinators, LLC 3001 Red Lion Road Philadelphia, PA 19114 | Wasserburger Arzneimittelwerk GmbH Herderstraβe 1,2 and Molkerei-Bauer-Straβe 18 83512 Wasserburg Germany | Labor LS SE & Co. KG Mangelsfeld 4, 5, 6, Bad Bocklet, Bavaria 97708 Germany | Solvias AG Römerpark 2 4303 Kaiseraugst Switzerland
Effective date: 2025-07-02
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 21:47:11

Label at a glance#

ProductDesferal

Active ingredientDEFEROXAMINE MESYLATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Desferal LBLDesferal PI USA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1731350	deferoxamine mesylate 500 MG Injection	PSN	1
1731352	Desferal 500 MG Injection	PSN	1
1731352	deferoxamine mesylate 500 MG Injection [Desferal]	SBD	1
1731350	deferoxamine mesylate 500 MG Injection	SCD	1
1731352	Desferal 500 MG Injection	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEFEROXAMINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Data Matrix	700712		Desferal LBL.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ef0d89c6-318e-9caf-5072-1f6976740df3	Product name	2	20171121

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
87081-467-91	Desferal	4 mL in 1 VIAL	INJECTION, POWDER, FOR SOLUTION	4		1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

Desferal
deferoxamine mesylate
DEFEROXAMINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
87081-467	87081-467-91

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEFEROXAMINE MESYLATE	V9TKO7EO6K	ACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N016267-001	DESFERAL	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982
N016267-002	DESFERAL	DEFEROXAMINE MESYLATE	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N016267-001	AP

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 3 · 86 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
2026-09-14 22:38:34	2026-08	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION	AP	RLD, RS	2000-05-25	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 47 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N016267-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016267-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016267-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016267-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016267-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016267-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016267-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016267-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016267-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016267-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016267-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016267-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016267-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016267-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016267-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016267-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016267-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016267-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016267-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016267-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N016267-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016267-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016267-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016267-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016267-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016267-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016267-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016267-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N016267-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016267-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N016267-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016267-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N016267-002	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016267-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016267-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016267-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016267-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016267-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016267-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016267-001	AP	1	`3f0d92c62455…`

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
Desferal	DEFEROXAMINE MESYLATE	MITEM PHARMA	38eff751-96c5-c48a-e063-6294a90a0e48	2025-07-02		Exact identifier ndc (package): 87081-467-91 ndc (product): 87081-467 ndc11 (package): 87081046791 spl id: 38eff751-96c6-c48a-e063-6294a90a0e48 spl set id: 38eff751-96c5-c48a-e063-6294a90a0e48

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.