Deferasirox

Product NDC: 45963-455
11-digit product format: 459630455
Labeler code: 45963
Product ID: 45963-455_ff13b6ff-e95c-47ed-b21b-6cac71aff318
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deferasirox
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA203560
Marketing category: ANDA
Marketing start: 2019-03-22
Marketing end: 0000-00-00
Substance: DEFERASIROX
Active strength: 250 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: 2024-12-31
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	45963-455		D	Discontinued by firm		2026-10-16
excluded package	package	45963-455	45963-455-30	D	Discontinued by firm		2026-10-16

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	TE codes	Approval date
A203560-001	DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26
A203560-002	DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26
A203560-003	DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A203560-001	AB
A203560-002	AB
A203560-003	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 4 · 132 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
2026-10-15 13:18:30	2026-09	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A203560-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203560-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A203560-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203560-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203560-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A203560-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203560-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203560-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203560-003	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203560-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203560-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203560-003	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A203560-001	PC	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203560-002	PC	2019-04-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203560-003	PC	2019-04-05	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A203560-001	PC	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203560-002	PC	2019-04-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A203560-003	PC	2019-04-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A203560-001	PC	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203560-002	PC	2019-04-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A203560-003	PC	2019-04-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A203560-001	PC	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203560-002	PC	2019-04-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A203560-003	PC	2019-04-05	`ea99ee380514…`

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
1e1ec29c-8ce7-9963-3c87-cf7d9cd3b139	Product name	5	20250624
0feb0248-301d-406d-9b41-7d80ddbec8a8	Product name	4	20201216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
45963-455-30	Deferasirox	30 in 1 BOTTLE	TABLET, FOR SUSPENSION	30		29

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
45963-455-30	EA - Each	45963-455	ec6d5a1b-1a01-40cd-bb34-bb7136053f11	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-455	DEFERASIROX TABLET, FOR SUSPENSION [ACTAVIS PHARMA, INC.]	28	Legacy NDC, 1 package rows	20241103_ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
597768	deferasirox 125 MG Tablet for Oral Suspension	PSN	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	29
597770	deferasirox 250 MG Tablet for Oral Suspension	PSN	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	29
597772	deferasirox 500 MG Tablet for Oral Suspension	PSN	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	29
597768	deferasirox 125 MG Tablet for Oral Suspension	SCD	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	29
597770	deferasirox 250 MG Tablet for Oral Suspension	SCD	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	29
597772	deferasirox 500 MG Tablet for Oral Suspension	SCD	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	29

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45963-455-30	45963045530	30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-455-30)	2019-03-22	0000-00-00	No	No	Current