Exjade

Product NDC: 0078-0470
11-digit product format: 000780470
Labeler code: 0078
Product ID: 0078-0470_17c39217-5502-420d-8d2e-799626756189
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: deferasirox
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA021882
Marketing category: NDA
Marketing start: 2005-11-30
Substance: DEFERASIROX
Active strength: 500 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

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
N021882-001	EXJADE	DEFERASIROX	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02
N021882-002	EXJADE	DEFERASIROX	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02
N021882-003	EXJADE	DEFERASIROX	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021882-001	AB
N021882-002	AB
N021882-003	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 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	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-002	EXJADE	250MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-003	EXJADE	500MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD, RS	2005-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021882-001	EXJADE	125MG	TABLET, FOR SUSPENSION / ORAL	AB	RLD	2005-11-02	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N021882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021882-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021882-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021882-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021882-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021882-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021882-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021882-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021882-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021882-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021882-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021882-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021882-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021882-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021882-001	AB	1	`8072bd15b7f6…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021882-001	6465504	2019-04-05	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021882-002	6465504	2019-04-05	Drug substance, Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021882-003	6465504	2019-04-05	Drug substance, Drug product	`ea99ee380514…`

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	N021882-001	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-001	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-002	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-002	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-003	M-241	2022-07-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021882-003	M-263	2023-07-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021882-001	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-001	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-002	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-002	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-003	M-241	2022-07-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021882-003	M-263	2023-07-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021882-001	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-001	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-002	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-002	M-263	2023-07-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-003	M-241	2022-07-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021882-003	M-263	2023-07-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021882-001	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-001	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-001	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-002	M-241	2022-07-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	ODE-39	2020-01-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	M-239	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021882-003	M-241	2022-07-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021882-001	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-001	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-002	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-002	M-263	2023-07-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-003	M-241	2022-07-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021882-003	M-263	2023-07-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021882-001	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-001	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-001	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-002	M-239	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-002	M-241	2022-07-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-002	M-263	2023-07-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021882-003	M-239	2021-12-12	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEFERASIROX	500 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
597768	Internal RxNorm lookup
597770	Internal RxNorm lookup
597772	Internal RxNorm lookup
616159	Internal RxNorm lookup
616161	Internal RxNorm lookup
616163	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
3495a70c-870c-4968-940e-8baea152cf85	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
0078-0470-15	Exjade	30 in 1 BOTTLE	TABLET, FOR SUSPENSION	30		49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0470-15	EA - Each	0078-0470	5de5b425-fd6c-4c0f-9377-d52dedbbd76c	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DEFERASIROX	ACTIVE INGREDIENT	V8G4MOF2V9	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
DEFERASIROX	ACTIVE MOIETY	V8G4MOF2V9	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0470	EXJADE (DEFERASIROX) TABLET, FOR SUSPENSION [NOVARTIS PHARMACEUTICALS CORPORATION]	45	Current NDC, Legacy NDC, 1 package rows	20240724_3495a70c-870c-4968-940e-8baea152cf85.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
Exjade	DEFERASIROX	Novartis Pharmaceuticals Corporation	3495a70c-870c-4968-940e-8baea152cf85	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021882 application number: NDA021882 ndc (product): 0078-0470

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	3495a70c-870c-4968-940e-8baea152cf85	49
597770	deferasirox 250 MG Tablet for Oral Suspension	PSN	3495a70c-870c-4968-940e-8baea152cf85	49
597772	deferasirox 500 MG Tablet for Oral Suspension	PSN	3495a70c-870c-4968-940e-8baea152cf85	49
616159	EXJADE 125 MG Tablet for Oral Suspension	PSN	3495a70c-870c-4968-940e-8baea152cf85	49
616161	EXJADE 250 MG Tablet for Oral Suspension	PSN	3495a70c-870c-4968-940e-8baea152cf85	49
616163	EXJADE 500 MG Tablet for Oral Suspension	PSN	3495a70c-870c-4968-940e-8baea152cf85	49
616159	deferasirox 125 MG Tablet for Oral Suspension [Exjade]	SBD	3495a70c-870c-4968-940e-8baea152cf85	49
616161	deferasirox 250 MG Tablet for Oral Suspension [Exjade]	SBD	3495a70c-870c-4968-940e-8baea152cf85	49
616163	deferasirox 500 MG Tablet for Oral Suspension [Exjade]	SBD	3495a70c-870c-4968-940e-8baea152cf85	49
597768	deferasirox 125 MG Tablet for Oral Suspension	SCD	3495a70c-870c-4968-940e-8baea152cf85	49
597770	deferasirox 250 MG Tablet for Oral Suspension	SCD	3495a70c-870c-4968-940e-8baea152cf85	49
597772	deferasirox 500 MG Tablet for Oral Suspension	SCD	3495a70c-870c-4968-940e-8baea152cf85	49
616159	Exjade 125 MG Tablet for Oral Suspension	SY	3495a70c-870c-4968-940e-8baea152cf85	49
616161	Exjade 250 MG Tablet for Oral Suspension	SY	3495a70c-870c-4968-940e-8baea152cf85	49
616163	Exjade 500 MG Tablet for Oral Suspension	SY	3495a70c-870c-4968-940e-8baea152cf85	49

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0470-15	00078047015	30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0470-15)	2005-11-30	0000-00-00	No	No	Current