Deferasirox

Product NDC: 45963-456
11-digit product format: 459630456
Labeler code: 45963
Product ID: 45963-456_daefa0d6-0d5a-48fe-897b-cbc3e1db47f7
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: 2026-09-30
Substance: DEFERASIROX
Active strength: 500 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
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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 · 123 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203560-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203560-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203560-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2016-01-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203560-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203560-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203560-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203560-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203560-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203560-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203560-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203560-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203560-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203560-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203560-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203560-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203560-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203560-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203560-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203560-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203560-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203560-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203560-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203560-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203560-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203560-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203560-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203560-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203560-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203560-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203560-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203560-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203560-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203560-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203560-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203560-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203560-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203560-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203560-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203560-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203560-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203560-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203560-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203560-001	AB	1	`8072bd15b7f6…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Deferasirox

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V8G4MOF2V9	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597768	Internal RxNorm lookup
597770	Internal RxNorm lookup
597772	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
ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	Available on FDA.report

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
45963-456-30	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
45963-456-30	EA - Each	45963-456	a9f5ef44-e947-446f-adcd-ef234c78b504	1	2019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45963-456	DEFERASIROX TABLET, FOR SUSPENSION [ACTAVIS PHARMA, INC.]	28	Current NDC, Legacy NDC, 1 package rows	20241103_ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Deferasirox	DEFERASIROX	Actavis Pharma, Inc.	ad73cb1f-41d6-4cde-9abc-fc2cb7e04c95	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203560 application number: ANDA203560 ndc (product): 45963-456

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
45963-456-30	45963045630	30 TABLET, FOR SUSPENSION in 1 BOTTLE (45963-456-30)	2019-03-22	2026-09-30	No	No	Current