DEFERASIROX

Product NDC: 70771-1410
11-digit product format: 707711410
Labeler code: 70771
Product ID: 70771-1410_da0c4f31-82fd-4012-ac7c-101f58ca3c31
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEFERASIROX
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Zydus Lifesciences Limited
Application: ANDA208882
Marketing category: ANDA
Marketing start: 2021-05-06
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: 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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	70771-1410		D	Discontinued by firm	2026-10-05
excluded package	package	70771-1410	70771-1410-1	D	Discontinued by firm	2026-10-05
excluded package	package	70771-1410	70771-1410-3	D	Discontinued by firm	2026-10-05
excluded package	package	70771-1410	70771-1410-9	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1410-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1410-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70771-1410-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1410-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1410-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70771-1410-1	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A208882-001	DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05
A208882-002	DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05
A208882-003	DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-11-12 02:37 UTC	2020-11	A208882-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208882-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208882-003	AB	1	`c0c555d07b60…`

Reported adverse events (FAERS/openFDA)#

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

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
70771-1410-1	70771141001	100 TABLET, FOR SUSPENSION in 1 BOTTLE (70771-1410-1)	2021-05-06	0000-00-00	No	No	Current
70771-1410-3	70771141003	30 TABLET, FOR SUSPENSION in 1 BOTTLE (70771-1410-3)	2021-05-06	0000-00-00	No	No	Current
70771-1410-9	70771141009	90 TABLET, FOR SUSPENSION in 1 BOTTLE (70771-1410-9)	2021-05-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deferasirox Tablets for Oral Suspension	Zydus Lifesciences Limited	2024-11-28	HUMAN PRESCRIPTION DRUG LABEL	4