Desferal

Product NDC: 87081-467
11-digit product format: 870810467
Labeler code: 87081
Product ID: 87081-467_38eff751-96c6-c48a-e063-6294a90a0e48
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferoxamine mesylate
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: MITEM PHARMA
Application: NDA016267
Marketing category: NDA
Marketing start: 1968-04-02
Substance: DEFEROXAMINE MESYLATE
Active strength: 500 mg/5mL
Pharmacologic classes: Iron Chelating Activity [MoA], Iron Chelator [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 · 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N016267-002	DESFERAL	DEFEROXAMINE MESYLATE	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25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 · 84 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	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N016267-002	DESFERAL	2GM/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION		RLD	2000-05-25	`caaa826d4ba7…`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…`
2022-03-09 01:35 UTC	2022-03	N016267-001	DESFERAL	500MG/VIAL	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N016267-002	DESFERAL	2GM/VIAL	INJECTABLE / INJECTION		RLD	2000-05-25	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2023-05-13 08:27 UTC	2023-05	N016267-001	AP	1	`053a50430f4f…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFEROXAMINE MESYLATE	500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V9TKO7EO6K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1731350	Internal RxNorm lookup
1731352	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
38eff751-96c5-c48a-e063-6294a90a0e48	Available on FDA.report

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

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 · 2 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 application applno (NDA): 016267 application number: NDA016267 ndc (product): 87081-467
Desferal	DEFEROXAMINE MESYLATE	Novartis Pharmaceuticals Corporation	a7174843-5965-49fc-b842-f7eff7b48bbc	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 016267 application number: NDA016267

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9TKO7EO6K	DEFEROXAMINE MESYLATE	138-14-7	DEFEROXAMINE MESYLATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1731350	deferoxamine mesylate 500 MG Injection	PSN	38eff751-96c5-c48a-e063-6294a90a0e48	1
1731352	Desferal 500 MG Injection	PSN	38eff751-96c5-c48a-e063-6294a90a0e48	1
1731352	deferoxamine mesylate 500 MG Injection [Desferal]	SBD	38eff751-96c5-c48a-e063-6294a90a0e48	1
1731350	deferoxamine mesylate 500 MG Injection	SCD	38eff751-96c5-c48a-e063-6294a90a0e48	1
1731352	Desferal 500 MG Injection	SY	38eff751-96c5-c48a-e063-6294a90a0e48	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
87081-467-91	87081046791	4 mL in 1 VIAL (87081-467-91)	4 ml	1968-04-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Desferal	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	2025-07-02	HUMAN PRESCRIPTION DRUG LABEL	1