Deferiprone

Product NDC: 0054-0576
11-digit product format: 000540576
Labeler code: 0054
Product ID: 0054-0576_85bc2162-59ea-409a-94c2-0edef74922f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deferiprone
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Hikma Pharmaceuticals USA Inc.
Application: ANDA213239
Marketing category: ANDA
Marketing start: 2021-06-03
Substance: DEFERIPRONE
Active strength: 500 mg/1
Pharmacologic classes: Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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	0054-0576	0054-0576-28	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 · 12 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…`

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
A213239-001	DEFERIPRONE	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29
A213239-002	DEFERIPRONE	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213239-001	AB
A213239-002	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 · 68 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	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB	RS	2022-02-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB		2022-02-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB		2022-02-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB		2022-02-08	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213239-002	DEFERIPRONE	1GM	TABLET / ORAL	AB		2022-02-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213239-001	DEFERIPRONE	500MG	TABLET / ORAL	AB		2021-03-29	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A213239-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213239-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213239-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213239-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213239-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213239-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213239-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213239-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213239-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213239-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213239-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213239-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213239-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213239-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213239-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213239-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213239-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213239-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213239-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213239-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213239-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213239-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213239-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213239-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213239-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213239-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213239-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213239-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213239-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213239-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213239-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213239-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213239-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A213239-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213239-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A213239-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213239-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213239-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213239-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213239-001	AB	1	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERIPRONE	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2BTY8KH53L	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
389242	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
d7ea0a84-c328-4636-8cd6-ad75f2074b22	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a80eb9dc-2190-fd13-788a-836e044e09a9	Product name	4	20210927
ee8776d9-85a0-4e53-8dc8-f4ae23ba4929	Product name	1	20201008
6708d2db-3abd-41fb-b674-120f69c5a63a	Product name	1	20180621
222e639a-0425-48b8-8bdb-5ab1d9731285	Product name	1	20151028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0054-0576-25	Deferiprone	100 in 1 BOTTLE	TABLET, COATED	100		8
0054-0576-28	Deferiprone	300 in 1 BOTTLE	TABLET, COATED	300		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0054-0576-25	EA - Each	0054-0576	5de2aa53-82c5-4bc4-b54a-ae2acd5efefe	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0054-0576	DEFERIPRONE TABLET, COATED [HIKMA PHARMACEUTICALS USA INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240215_d7ea0a84-c328-4636-8cd6-ad75f2074b22.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
Deferiprone	DEFERIPRONE	Hikma Pharmaceuticals USA Inc.	d7ea0a84-c328-4636-8cd6-ad75f2074b22	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213239 application number: ANDA213239 ndc (product): 0054-0576
Deferiprone	DEFERIPRONE	Hikma Pharmaceuticals USA Inc.	c4f9e9be-39e7-4940-9cb0-f17772d7e524	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213239 application number: ANDA213239

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2BTY8KH53L	DEFERIPRONE	30652-11-0	DEFERIPRONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
389242	deferiprone 500 MG Three-Times-A-Day Oral Tablet	PSN	d7ea0a84-c328-4636-8cd6-ad75f2074b22	8
389242	deferiprone 500 MG Oral Tablet	SCD	d7ea0a84-c328-4636-8cd6-ad75f2074b22	8
389242	deferiprone 500 MG Three-Times-A-Day Oral Tablet	SY	d7ea0a84-c328-4636-8cd6-ad75f2074b22	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0054-0576-25	00054057625	100 TABLET, COATED in 1 BOTTLE (0054-0576-25)	2021-06-03	0000-00-00	No	No	Current
0054-0576-28	00054057628	300 TABLET, COATED in 1 BOTTLE (0054-0576-28)	2021-06-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deferiprone	Hikma Pharmaceuticals USA Inc. \| West-Ward Columbus Inc.	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	8