deferasirox

Product NDC: 69097-391
11-digit product format: 690970391
Labeler code: 69097
Product ID: 69097-391_dfe125b8-f47a-4e92-96f2-08eff47d838f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferasirox
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Cipla USA Inc.
Application: ANDA211852
Marketing category: ANDA
Marketing start: 2020-02-13
Marketing end: 0000-00-00
Substance: DEFERASIROX
Active strength: 90 mg/1
Pharmacologic classes: Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	69097-391		D	Discontinued by firm	2026-10-02
excluded package	package	69097-391	69097-391-02	D	Discontinued by firm	2026-10-02
excluded package	package	69097-391	69097-391-20	D	Discontinued by firm	2026-10-02

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
A211852-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11
A211852-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11
A211852-003	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 · 117 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	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211852-002	DEFERASIROX	360MG	TABLET / ORAL	2020-02-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211852-003	DEFERASIROX	180MG	TABLET / ORAL	2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211852-001	DEFERASIROX	90MG	TABLET / ORAL	2020-02-11	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

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	A211852-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211852-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211852-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211852-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211852-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211852-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211852-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211852-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211852-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211852-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211852-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211852-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211852-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211852-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211852-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211852-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211852-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211852-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211852-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211852-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211852-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211852-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211852-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211852-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211852-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211852-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A211852-003	AB	1	`c0c555d07b60…`
2023-01-26 05:58 UTC	2023-01	A211852-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211852-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A211852-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211852-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211852-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211852-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211852-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211852-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A211852-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211852-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211852-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A211852-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211852-001	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
69097-391-02	EA - Each	69097-391	a73e1282-2c66-4ef4-ba3e-cf325eb4ef66	1	2020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69097-391	DEFERASIROX TABLET, COATED [CIPLA USA INC.]	5	Legacy NDC	20211103_31df70cb-f6a0-4cba-a02c-dc9fa6bd63bd.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
69097-391-02	69097039102	30 TABLET, COATED in 1 BOTTLE (69097-391-02)		2020-02-13	0000-00-00	No	No	Current
69097-391-20	69097039120	5 BLISTER PACK in 1 CARTON (69097-391-20) > 10 TABLET, COATED in 1 BLISTER PACK (69097-391-19)	5 blister pack	2020-02-13	0000-00-00	No	No	Current