Deferoxamine mesylate

Product NDC: 52609-4505
Requested package NDC: 52609-4505-6
11-digit product format: 526094505
Labeler code: 52609
Product ID: 52609-4505_cbc75c16-6c82-869c-84a8-deaa76ebdb1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deferoxamine mesylate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: ApoPharma USA, Inc.
Application: ANDA207384
Marketing category: ANDA
Marketing start: 2018-03-23
Marketing end: 0000-00-00
Substance: DEFEROXAMINE MESYLATE
Active strength: 500 mg/1
Pharmacologic classes: Iron Chelating Activity [MoA],Iron Chelator [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52609-4505	52609-4505-6	I	Inactivated by FDA		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A207384-001	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP		2017-09-29
A207384-002	DEFEROXAMINE MESYLATE	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP		2017-09-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207384-001	AP
A207384-002	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 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	A207384-001	AP	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207384-002	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207384-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207384-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207384-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207384-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207384-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207384-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207384-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207384-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207384-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207384-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207384-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207384-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207384-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207384-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207384-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207384-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207384-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207384-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207384-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207384-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207384-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207384-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207384-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207384-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207384-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207384-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207384-002	AP	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52609-4505-6	2022-01-28	C162847	48780-1	d6a99b39-ea01-a426-e053-dadaa90af4c2	Deferoxamine Mesylate for Injection, USP Vials Rx only Prescribing Information

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52609-4505-6	Deferoxamine mesylate	4 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	4		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52609-4505-6	EA - Each	52609-4505	9390ebe9-06ce-4f67-9c0c-927fd598076a	1	2018-05-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52609-4505	DEFEROXAMINE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOPHARMA USA, INC.]	1	Legacy NDC, 1 package rows	20180327_72348776-4971-bc49-8b66-67a2422567d4.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Deferoxamine mesylate	DEFEROXAMINE MESYLATE	Apotex Corp.	c99553fb-3fae-b88a-6c2c-efa7520197f9	2026-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207384 application number: ANDA207384
Deferoxamine mesylate	DEFEROXAMINE MESYLATE	Gland Pharma Limited	598fba68-f46e-4b6e-894c-63c2940b2063	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207384 application number: ANDA207384

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
1731345	deferoxamine mesylate 2 GM Injection	PSN	72348776-4971-bc49-8b66-67a2422567d4	1
1731350	deferoxamine mesylate 500 MG Injection	PSN	72348776-4971-bc49-8b66-67a2422567d4	1
1731345	deferoxamine mesylate 2000 MG Injection	SCD	72348776-4971-bc49-8b66-67a2422567d4	1
1731350	deferoxamine mesylate 500 MG Injection	SCD	72348776-4971-bc49-8b66-67a2422567d4	1
1731345	deferoxamine mesylate 2 GM Injection	SY	72348776-4971-bc49-8b66-67a2422567d4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52609-4505-6	52609450506	4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (52609-4505-6)	2018-03-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deferoxamine Mesylate for Injection, USP Vials Rx only Prescribing Information	ApoPharma USA, Inc. \| Gland Pharma Limited	2018-03-23	HUMAN PRESCRIPTION DRUG LABEL	1