Jadenu

Product NDC: 0078-0656
11-digit product format: 000780656
Labeler code: 0078
Product ID: 0078-0656_028e6158-3b78-41dd-99a8-6acb582f7245
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferasirox
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA206910
Marketing category: NDA
Marketing start: 2015-03-30
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: 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	TE codes	RLD / RS	Approval date
N206910-001	JADENU	DEFERASIROX	90MG	TABLET / ORAL	AB	RLD	2015-03-30
N206910-002	JADENU	DEFERASIROX	180MG	TABLET / ORAL	AB	RLD	2015-03-30
N206910-003	JADENU	DEFERASIROX	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N206910-001	AB
N206910-002	AB
N206910-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Coverage / status	Submission date
N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11
N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11
N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11

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 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-002	JADENU	180MG	TABLET / ORAL	AB	RLD	2015-03-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-003	JADENU	360MG	TABLET / ORAL	AB	RLD, RS	2015-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206910-001	JADENU	90MG	TABLET / ORAL	AB	RLD	2015-03-30	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 113 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	N206910-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206910-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206910-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206910-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 135 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-002	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206910-003	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206910-001	9283209	2034-11-21	Drug substance, Drug product	2016-04-11	`8072bd15b7f6…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-001	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-001	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-002	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-002	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-003	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206910-003	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206910-001	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-001	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-002	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-002	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-003	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206910-003	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206910-001	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-001	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-002	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-002	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-003	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206910-003	M-263	2023-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206910-001	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-001	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-001	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-002	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-002	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-002	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-003	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-003	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206910-003	M-241	2022-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206910-001	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-001	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-002	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-002	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-003	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206910-003	M-263	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206910-001	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-001	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-001	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-002	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-002	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-002	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206910-003	M-239	2021-12-12	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	360 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 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1607784	Internal RxNorm lookup
1607790	Internal RxNorm lookup
1607792	Internal RxNorm lookup
1607794	Internal RxNorm lookup
1607796	Internal RxNorm lookup
1607798	Internal RxNorm lookup
1923822	Internal RxNorm lookup
1923825	Internal RxNorm lookup
1923826	Internal RxNorm lookup
1923827	Internal RxNorm lookup
1923828	Internal RxNorm lookup
1923829	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
fee89140-fff1-4443-9f42-24ac004fcda1	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
0078-0656-15	Jadenu	30 in 1 BOTTLE	TABLET, FILM COATED	30		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0656-15	EA - Each	0078-0656	01211b15-166b-4abd-a080-be6fc77ebb3f	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEFERASIROX	ACTIVE INGREDIENT	V8G4MOF2V9	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
DEFERASIROX	ACTIVE MOIETY	V8G4MOF2V9	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	JADENU (DEFERASIROX) TABLET, FILM COATED [NOVARTIS PHARMACEUTICALS CORPORATION]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0656	JADENU (DEFERASIROX) TABLET, FILM COATED JADENU (DEFERASIROX) GRANULE [NOVARTIS PHARMACEUTICALS CORPORATION]	23	Current NDC, Legacy NDC, 1 package rows	20250503_fee89140-fff1-4443-9f42-24ac004fcda1.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
Jadenu	DEFERASIROX	Novartis Pharmaceuticals Corporation	fee89140-fff1-4443-9f42-24ac004fcda1	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 206910 application number: NDA206910 ndc (product): 0078-0656

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
1923828	deferasirox 180 MG Oral Granules	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607784	deferasirox 180 MG Oral Tablet	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923826	deferasirox 360 MG Oral Granules	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607792	deferasirox 360 MG Oral Tablet	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923822	deferasirox 90 MG Oral Granules	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607796	deferasirox 90 MG Oral Tablet	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607790	Jadenu 180 MG Oral Tablet	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607794	Jadenu 360 MG Oral Tablet	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607798	Jadenu 90 MG Oral Tablet	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923829	Jadenu Sprinkle 180 MG Oral Granules	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923827	Jadenu Sprinkle 360 MG Oral Granules	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923825	Jadenu Sprinkle 90 MG Oral Granules	PSN	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923829	deferasirox 180 MG Oral Granules [Jadenu]	SBD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607790	deferasirox 180 MG Oral Tablet [Jadenu]	SBD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923827	deferasirox 360 MG Oral Granules [Jadenu]	SBD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607794	deferasirox 360 MG Oral Tablet [Jadenu]	SBD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923825	deferasirox 90 MG Oral Granules [Jadenu]	SBD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607798	deferasirox 90 MG Oral Tablet [Jadenu]	SBD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923828	deferasirox 180 MG Oral Granules	SCD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607784	deferasirox 180 MG Oral Tablet	SCD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923826	deferasirox 360 MG Oral Granules	SCD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607792	deferasirox 360 MG Oral Tablet	SCD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923822	deferasirox 90 MG Oral Granules	SCD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607796	deferasirox 90 MG Oral Tablet	SCD	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923829	Jadenu 180 MG Oral Granules	SY	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607790	Jadenu 180 MG Oral Tablet	SY	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923827	Jadenu 360 MG Oral Granules	SY	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607794	Jadenu 360 MG Oral Tablet	SY	fee89140-fff1-4443-9f42-24ac004fcda1	26
1923825	Jadenu 90 MG Oral Granules	SY	fee89140-fff1-4443-9f42-24ac004fcda1	26
1607798	Jadenu 90 MG Oral Tablet	SY	fee89140-fff1-4443-9f42-24ac004fcda1	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0656-15	00078065615	30 TABLET, FILM COATED in 1 BOTTLE (0078-0656-15)	2015-03-30	0000-00-00	No	No	Current