Deferasirox

Product NDC: 69238-1486
11-digit product format: 692381486
Labeler code: 69238
Product ID: 69238-1486_0b0b3d91-33d4-46b8-8bdc-fb9b5a9e99c7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Deferasirox
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Amneal Pharmaceuticals NY LLC
Application: ANDA210727
Marketing category: ANDA
Marketing start: 2020-01-02
Substance: DEFERASIROX
Active strength: 90 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

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	Approval date
A210727-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27
A210727-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27
A210727-003	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210727-002	DEFERASIROX	360MG	TABLET / ORAL	2019-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210727-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210727-001	DEFERASIROX	90MG	TABLET / ORAL	2019-12-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-08 23:34 UTC	2022-04	A210727-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210727-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210727-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210727-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210727-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A210727-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210727-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210727-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210727-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A210727-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210727-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210727-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210727-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210727-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210727-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210727-003	AB	1	`c0c555d07b60…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	90 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
1607784	Internal RxNorm lookup
1607792	Internal RxNorm lookup
1607796	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
a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	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
69238-1486-3	Deferasirox	30 in 1 BOTTLE	TABLET, FILM COATED	30		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69238-1486-3	EA - Each	69238-1486	55169a4c-8fe5-4042-ad46-75561cfe42ed	1	2020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69238-1486	DEFERASIROX TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]	13	Current NDC, Legacy NDC, 1 package rows	20231230_a7ae9c31-e14f-4cf9-9ab3-850519f1a87c.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	Amneal Pharmaceuticals NY LLC	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	2020-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210727 application number: ANDA210727 ndc (product): 69238-1486

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
1607784	deferasirox 180 MG Oral Tablet	PSN	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	13
1607792	deferasirox 360 MG Oral Tablet	PSN	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	13
1607796	deferasirox 90 MG Oral Tablet	PSN	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	13
1607784	deferasirox 180 MG Oral Tablet	SCD	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	13
1607792	deferasirox 360 MG Oral Tablet	SCD	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	13
1607796	deferasirox 90 MG Oral Tablet	SCD	a7ae9c31-e14f-4cf9-9ab3-850519f1a87c	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69238-1486-3	69238148603	30 TABLET, FILM COATED in 1 BOTTLE (69238-1486-3)	2020-01-02	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Deferasirox	Amneal Pharmaceuticals NY LLC \| Amneal Pharmaceuticals Private Limited	2020-10-29	HUMAN PRESCRIPTION DRUG LABEL	13