Deferasirox

Product NDC: 46708-324
11-digit product format: 467080324
Labeler code: 46708
Product ID: 46708-324_3b7b2b3c-507c-4ea9-a45d-f5e38f9e1b80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deferasirox
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA210060
Marketing category: ANDA
Marketing start: 2019-11-21
Substance: DEFERASIROX
Active strength: 125 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: 2026-12-31
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
A210060-001	DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20
A210060-002	DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20
A210060-003	DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210060-001	AB
A210060-002	AB
A210060-003	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 3 · 114 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	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210060-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210060-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210060-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 114 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	A210060-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210060-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210060-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210060-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210060-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210060-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210060-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210060-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210060-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210060-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210060-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210060-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210060-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210060-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210060-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210060-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210060-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210060-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210060-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210060-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210060-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210060-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210060-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210060-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210060-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210060-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210060-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210060-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210060-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210060-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210060-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210060-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210060-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210060-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210060-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210060-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210060-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210060-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210060-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210060-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	125 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
8c8b84f3-6887-4485-b5e0-03f254b88a15	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
46708-324-30	2023-02-01	C162847	48780-1	f386c649-e6ee-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DEFERASIROX TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for DEFERASIROX TABLETS FOR ORAL SUSPENSION. DEFERASIROX tablets for oral suspension Initial U.S. Approval: 2005
46708-324-30	2023-01-30	C162847	48780-1	f386c649-e6ee-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use DEFERASIROX TABLETS FOR ORAL SUSPENSION safely and effectively. See full prescribing information for DEFERASIROX TABLETS FOR ORAL SUSPENSION. DEFERASIROX tablets for oral suspension Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
46708-324-30	Deferasirox	30 in 1 BOTTLE	TABLET, FOR SUSPENSION	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-324	DEFERASIROX TABLET, FOR SUSPENSION [ALEMBIC PHARMACEUTICALS LIMITED]	2	Current NDC, Legacy NDC, 1 package rows	20230202_8c8b84f3-6887-4485-b5e0-03f254b88a15.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
Deferasirox	DEFERASIROX	Alembic Pharmaceuticals Inc.	1f9f1a69-bf71-4e6a-88b0-90f08c4da79f	2023-03-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210060 application number: ANDA210060
Deferasirox	DEFERASIROX	Alembic Pharmaceuticals Limited	8c8b84f3-6887-4485-b5e0-03f254b88a15	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210060 application number: ANDA210060 ndc (product): 46708-324

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	8c8b84f3-6887-4485-b5e0-03f254b88a15	2
597770	deferasirox 250 MG Tablet for Oral Suspension	PSN	8c8b84f3-6887-4485-b5e0-03f254b88a15	2
597772	deferasirox 500 MG Tablet for Oral Suspension	PSN	8c8b84f3-6887-4485-b5e0-03f254b88a15	2
597768	deferasirox 125 MG Tablet for Oral Suspension	SCD	8c8b84f3-6887-4485-b5e0-03f254b88a15	2
597770	deferasirox 250 MG Tablet for Oral Suspension	SCD	8c8b84f3-6887-4485-b5e0-03f254b88a15	2
597772	deferasirox 500 MG Tablet for Oral Suspension	SCD	8c8b84f3-6887-4485-b5e0-03f254b88a15	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
46708-324-30	46708032430	30 TABLET, FOR SUSPENSION in 1 BOTTLE (46708-324-30)	2019-11-21	0000-00-00	No	No	Current