Deferasirox

Product NDC: 69452-161
11-digit product format: 694520161
Labeler code: 69452
Product ID: 69452-161_2f9b625f-3835-4481-e063-6394a90a4bf3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferasirox
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA210920
Marketing category: ANDA
Marketing start: 2018-09-28
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
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
A210920-001	DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20
A210920-002	DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20
A210920-003	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
A210920-001	AB
A210920-002	AB
A210920-003	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	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210920-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210920-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210920-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2019-11-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210920-001	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	A210920-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210920-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210920-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210920-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210920-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210920-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210920-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210920-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210920-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210920-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210920-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210920-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210920-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210920-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210920-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210920-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210920-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210920-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210920-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210920-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210920-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210920-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210920-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210920-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210920-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210920-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210920-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210920-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210920-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210920-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210920-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210920-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210920-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210920-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210920-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210920-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210920-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210920-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210920-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210920-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Bionpharma Inc.	dc690f20-533e-490e-b13d-143382e02351	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210920 application number: ANDA210920 ndc (product): 69452-161

Additional Listing Data#

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

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
dc690f20-533e-490e-b13d-143382e02351	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
69452-161-13	Deferasirox	30 in 1 BOTTLE	TABLET, FOR SUSPENSION	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-161-13	EA - Each	69452-161	75c2ba0d-afd3-4674-a7f0-327f62546ea0	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-161	DEFERASIROX TABLET, FOR SUSPENSION [BIONPHARMA INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250308_dc690f20-533e-490e-b13d-143382e02351.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	dc690f20-533e-490e-b13d-143382e02351	4
597770	deferasirox 250 MG Tablet for Oral Suspension	PSN	dc690f20-533e-490e-b13d-143382e02351	4
597772	deferasirox 500 MG Tablet for Oral Suspension	PSN	dc690f20-533e-490e-b13d-143382e02351	4
597768	deferasirox 125 MG Tablet for Oral Suspension	SCD	dc690f20-533e-490e-b13d-143382e02351	4
597770	deferasirox 250 MG Tablet for Oral Suspension	SCD	dc690f20-533e-490e-b13d-143382e02351	4
597772	deferasirox 500 MG Tablet for Oral Suspension	SCD	dc690f20-533e-490e-b13d-143382e02351	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-161-13	69452016113	30 TABLET, FOR SUSPENSION in 1 BOTTLE (69452-161-13)	2018-09-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deferasirox	Bionpharma Inc. \| Bluepharma Indústria Farmacêutica, S.A. \| APPCO PHARMA LLC	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	4