DEFERASIROX

Product NDC: 57664-770
Requested package NDC: 57664-770-83
11-digit product format: 576640770
Labeler code: 57664
Product ID: 57664-770_efa46505-78df-53ff-e053-2a95a90a309a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEFERASIROX
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA211641
Marketing category: ANDA
Marketing start: 2020-01-02
Marketing end: 0000-00-00
Substance: DEFERASIROX
Active strength: 360 mg/1
Pharmacologic classes: Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57664-770	57664-770-83	D	Discontinued by firm		2026-10-05

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A211641-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	2020-01-02
A211641-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	2020-01-02
A211641-003	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15

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 · 117 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	A211641-001	DEFERASIROX	90MG	TABLET / ORAL		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211641-002	DEFERASIROX	360MG	TABLET / ORAL		2020-01-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211641-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211641-001	DEFERASIROX	90MG	TABLET / ORAL		2020-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211641-002	DEFERASIROX	360MG	TABLET / ORAL		2020-01-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211641-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211641-001	DEFERASIROX	90MG	TABLET / ORAL		2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211641-002	DEFERASIROX	360MG	TABLET / ORAL		2020-01-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211641-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211641-001	DEFERASIROX	90MG	TABLET / ORAL		2020-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211641-002	DEFERASIROX	360MG	TABLET / ORAL		2020-01-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211641-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211641-001	DEFERASIROX	90MG	TABLET / ORAL		2020-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211641-002	DEFERASIROX	360MG	TABLET / ORAL		2020-01-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211641-003	DEFERASIROX	180MG	TABLET / ORAL		2020-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211641-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2020-01-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211641-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211641-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2020-01-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 99 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211641-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211641-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211641-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211641-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211641-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211641-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211641-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211641-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211641-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211641-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211641-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211641-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211641-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211641-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211641-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211641-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211641-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211641-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211641-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211641-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211641-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211641-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211641-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211641-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211641-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211641-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211641-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211641-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211641-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211641-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211641-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211641-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211641-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211641-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211641-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211641-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211641-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211641-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211641-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211641-001	AB	1	`4b0b4de00fa7…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57664-770	DEFERASIROX TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	8	Legacy NDC	20240927_53e645f5-3b29-4c9c-a620-b14f85be5ad4.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V8G4MOF2V9	DEFERASIROX	201530-41-8	DEFERASIROX

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-770-83	57664077083	30 TABLET, FILM COATED in 1 BOTTLE (57664-770-83)	2020-01-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEFERASIROX	Sun Pharmaceutical Industries, Inc. \| ALKALOIDA Chemical Company Zrt.	2024-09-26	HUMAN PRESCRIPTION DRUG LABEL	8