deferasirox

Product NDC: 69238-1704
Requested package NDC: 69238-1704-3
11-digit product format: 692381704
Labeler code: 69238
Product ID: 69238-1704_30a9b4e3-6d26-43b3-87ba-855df34c9e8d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferasirox
Dosage form: GRANULE
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA214194
Marketing category: ANDA
Marketing start: 2021-02-09
Marketing end: 0000-00-00
Substance: DEFERASIROX
Active strength: 360 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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69238-1704	69238-1704-3	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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69238-1704	69238-1704-3	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A214194-001	DEFERASIROX	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09
A214194-002	DEFERASIROX	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09
A214194-003	DEFERASIROX	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02

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 · 109 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	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214194-002	DEFERASIROX	360MG	GRANULE / ORAL	2021-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214194-003	DEFERASIROX	90MG	GRANULE / ORAL	2021-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214194-001	DEFERASIROX	180MG	GRANULE / ORAL	2021-02-09	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214194-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214194-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214194-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214194-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214194-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214194-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214194-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214194-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214194-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214194-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214194-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214194-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214194-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214194-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214194-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214194-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A214194-002	AB	1	`5aa47cf7b7d7…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214194-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214194-002	AB	1	`cb3db0bc1861…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1704-1	EA - Each	69238-1704	0210cedc-15fa-4185-925c-46132f9149da	1	2021-03-02
69238-1704-3	EA - Each	69238-1704	db82a174-4eaa-447b-a0d9-3ef53a96f205	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1704	DEFERASIROX GRANULE [AMNEAL PHARMACEUTICALS NY LLC]	14	Legacy NDC	20231230_19f4b412-3d35-4e31-80b6-f13d26c300c5.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1704-3	69238170403	30 PACKET in 1 CARTON (69238-1704-3) > 1 GRANULE in 1 PACKET (69238-1704-1)	30 packet	2021-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
deferasirox - Amneal Pharmaceuticals NY LLC	Amneal Pharmaceuticals NY LLC	2021-05-29	HUMAN PRESCRIPTION DRUG LABEL	14