deferasirox

Product NDC: 68462-494
11-digit product format: 684620494
Labeler code: 68462
Product ID: 68462-494_1eeaa820-150f-484b-b5b0-f57415f49083
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferasirox
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA209433
Marketing category: ANDA
Marketing start: 2020-01-06
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: 2027-12-31
Current FDA listing: Yes

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	68462-494	68462-494-30	D	Discontinued by firm		2026-10-15

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 · 2 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	68462-494	68462-494-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68462-494	68462-494-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`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	TE codes	Approval date
A209433-001	DEFERASIROX	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06
A209433-002	DEFERASIROX	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06
A209433-003	DEFERASIROX	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209433-001	AB
A209433-002	AB
A209433-003	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 · 120 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
2026-10-15 13:18:30	2026-09	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 120 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209433-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209433-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209433-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209433-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209433-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209433-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209433-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209433-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209433-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209433-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209433-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209433-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209433-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209433-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209433-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209433-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209433-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209433-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209433-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209433-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209433-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209433-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209433-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209433-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209433-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209433-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209433-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209433-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209433-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209433-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209433-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A209433-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209433-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209433-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A209433-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209433-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209433-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A209433-003	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209433-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209433-002	AB	1	`6a51e52b5d6a…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: deferasirox
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	125 mg/1

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
68462-494-30	deferasirox	30 in 1 BOTTLE	TABLET, FOR SUSPENSION	30		5
68462-494-90	deferasirox	90 in 1 BOTTLE	TABLET, FOR SUSPENSION	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-494-30	EA - Each	68462-494	fa45fc9c-2f87-4426-9018-2963aaabb6b0	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-494	DEFERASIROX TABLET, FOR SUSPENSION [GLENMARK PHARMACEUTICALS INC., USA]	5	Current NDC, Legacy NDC, 2 package rows	20241127_59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c.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	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	5
597770	deferasirox 250 MG Tablet for Oral Suspension	PSN	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	5
597772	deferasirox 500 MG Tablet for Oral Suspension	PSN	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	5
597768	deferasirox 125 MG Tablet for Oral Suspension	SCD	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	5
597770	deferasirox 250 MG Tablet for Oral Suspension	SCD	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	5
597772	deferasirox 500 MG Tablet for Oral Suspension	SCD	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-494-30	68462049430	30 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-30)	2020-01-06	0000-00-00	No	No	Current
68462-494-90	68462049490	90 TABLET, FOR SUSPENSION in 1 BOTTLE (68462-494-90)	2020-01-06	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
deferasirox	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-10-09	HUMAN PRESCRIPTION DRUG LABEL	6