deferasirox

Product NDC: 68462-494
Requested package NDC: 68462-494-30
11-digit product format: 684620494
Labeler code: 68462
Product ID: 68462-494_e2349a09-1e53-462c-b185-225ca0a400a4
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: 2026-12-31
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		2026-08-03

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 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
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 · 111 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	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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209433-002	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209433-003	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209433-001	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	2020-01-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 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	A209433-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209433-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209433-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209433-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209433-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209433-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209433-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209433-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209433-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209433-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209433-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209433-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209433-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209433-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209433-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209433-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209433-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209433-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209433-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209433-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209433-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209433-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209433-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209433-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209433-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209433-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209433-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209433-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209433-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209433-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209433-001	AB	1	`79d66fd596c7…`
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	125 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
59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	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
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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	Glenmark Pharmaceuticals Inc., USA	59f1d3fb-5bdb-4261-8557-9a4bde8b3c1c	2024-11-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209433 application number: ANDA209433 ndc (package): 68462-494-30 ndc (product): 68462-494 ndc11 (package): 68462049430

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
deferasirox	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2024-11-26	HUMAN PRESCRIPTION DRUG LABEL	5