Deferoxamine mesylate

Product NDC: 60505-6238
11-digit product format: 605056238
Labeler code: 60505
Product ID: 60505-6238_623ee6cc-3fc4-5f3b-3c68-741f52ccd71f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deferoxamine mesylate
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler: Apotex Corp.
Application: ANDA207384
Marketing category: ANDA
Marketing start: 2022-03-28
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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	60505-6238		D	Discontinued by firm		2026-08-17
excluded package	package	60505-6238	60505-6238-6	D	Discontinued by firm		2026-08-17

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, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	60505-6238-6	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	60505-6238-6	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	60505-6238-6	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	60505-6238-6	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	60505-6238-6	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	60505-6238-6	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	60505-6238-6	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	60505-6238-6	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	60505-6238-6	`0efc9e666f02…`	`f202fb6c5f17…`

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
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 · 84 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
2026-08-18 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…`
2022-03-09 01:35 UTC	2022-03	A207384-001	DEFEROXAMINE MESYLATE	500MG/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207384-002	DEFEROXAMINE MESYLATE	2GM/VIAL	INJECTABLE / INJECTION	AP	2017-09-29	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	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…`
2022-03-09 01:35 UTC	2022-03	A207384-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207384-002	AP	1	`bb7c543d1eb4…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-6238-6	EA - Each	60505-6238	6096fbec-0409-4fd5-9eb3-24a070a4f7b9	1	2022-04-06

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
60505-6238-6	60505623806	4 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 CARTON (60505-6238-6)	2022-03-28	0000-00-00	No	No	Current