DEFERASIROX

Product NDC: 70710-1012
11-digit product format: 707101012
Labeler code: 70710
Product ID: 70710-1012_3e05f5bd-bd51-485f-97dd-5817d3f37658
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: DEFERASIROX
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
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	70710-1012		D	Discontinued by firm	2026-10-16
excluded package	package	70710-1012	70710-1012-1	D	Discontinued by firm	2026-10-16
excluded package	package	70710-1012	70710-1012-3	D	Discontinued by firm	2026-10-16
excluded package	package	70710-1012	70710-1012-9	D	Discontinued by firm	2026-10-16

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	70710-1012-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70710-1012-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70710-1012-3	`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	70710-1012-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70710-1012-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70710-1012-3	`f5e01cc5f278…`	`a2eaf40c39c3…`

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	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 3 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208882-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208882-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208882-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	2020-05-05	`a50c72e98297…`

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
70710-1012-1	70710101201	100 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-1)	2021-05-06	0000-00-00	No	No	Current
70710-1012-3	70710101203	30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3)	2021-05-06	0000-00-00	No	No	Current
70710-1012-9	70710101209	90 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-9)	2021-05-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DEFERASIROX	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2024-02-20	HUMAN PRESCRIPTION DRUG LABEL	4