DEFERASIROX TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-26
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-05-31 21:18:22

Label at a glance#

Productdeferasirox

Active ingredientDEFERASIROX

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1471-3

Deferasirox tablets, 90 mg

30 Tablets

Rx only

NDC 70771-1472-3

Deferasirox tablets, 180 mg

30 Tablets

Rx only

NDC 70771-1473-3

Deferasirox tablets, 360 mg

30 Tablets

Rx only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1607784	deferasirox 180 MG Oral Tablet	PSN	6
1607792	deferasirox 360 MG Oral Tablet	PSN	6
1607796	deferasirox 90 MG Oral Tablet	PSN	6
1607784	deferasirox 180 MG Oral Tablet	SCD	6
1607792	deferasirox 360 MG Oral Tablet	SCD	6
1607796	deferasirox 90 MG Oral Tablet	SCD	6

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DEFERASIROX Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

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	SPL version
70771-1471-1	deferasirox	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1471-3	deferasirox	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1472-1	deferasirox	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1472-3	deferasirox	30 in 1 BOTTLE	TABLET, FILM COATED	30	6
70771-1473-1	deferasirox	100 in 1 BOTTLE	TABLET, FILM COATED	100	6
70771-1473-3	deferasirox	30 in 1 BOTTLE	TABLET, FILM COATED	30	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1471	DEFERASIROX TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241130_fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98.zip
70771-1472	DEFERASIROX TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241130_fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98.zip
70771-1473	DEFERASIROX TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	6	Current NDC, Legacy NDC, 2 package rows	20241130_fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

deferasirox
CROSCARMELLOSE SODIUM
HYPROMELLOSE 2910 (6 MPA.S)
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLOXAMER 407
POLYETHYLENE GLYCOL 8000
POVIDONE K30
SILICON DIOXIDE
TALC
TITANIUM DIOXIDE
D&C RED NO. 27
FD&C BLUE NO. 2
FERRIC OXIDE YELLOW

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1471	70771-1471-3, 70771-1471-1
70771-1472	70771-1472-3, 70771-1472-1
70771-1473	70771-1473-3, 70771-1473-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DEFERASIROX	V8G4MOF2V9	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DEFERASIROX	V8G4MOF2V9	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
D&C RED NO. 27	2LRS185U6K	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DEFERASIROX	V8G4MOF2V9	ACTIB
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
FD&C BLUE NO. 2	L06K8R7DQK	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
HYPROMELLOSE 2910 (6 MPA.S)	0WZ8WG20P6	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MICROCRYSTALLINE CELLULOSE	OP1R32D61U	IACT
POLOXAMER 407	TUF2IVW3M2	IACT
POLYETHYLENE GLYCOL 8000	Q662QK8M3B	IACT
POVIDONE K30	U725QWY32X	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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	TE codes	Approval date
A211383-001	DEFERASIROX	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20
A211383-002	DEFERASIROX	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20
A211383-003	DEFERASIROX	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211383-001	AB
A211383-002	AB
A211383-003	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 · 119 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
2026-09-14 22:38:34	2026-08	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-002	DEFERASIROX	360MG	TABLET / ORAL	AB	2019-11-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-003	DEFERASIROX	180MG	TABLET / ORAL	AB	2020-06-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211383-001	DEFERASIROX	90MG	TABLET / ORAL	AB	2019-11-20	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211383-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211383-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211383-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211383-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211383-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211383-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211383-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211383-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211383-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211383-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211383-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211383-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211383-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211383-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211383-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211383-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211383-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211383-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211383-001	AB	1	`301d65b070ca…`

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	Zydus Lifesciences Limited	fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98	2024-11-26		Exact identifier ndc (package): 70771-1471-1 ndc (package): 70771-1473-1 ndc (package): 70771-1471-3 ndc (package): 70771-1472-1 ndc (package): 70771-1472-3 ndc (package): 70771-1473-3 ndc (product): 70771-1472 ndc (product): 70771-1473 ndc (product): 70771-1471 ndc11 (package): 70771147103 ndc11 (package): 70771147201 ndc11 (package): 70771147303 ndc11 (package): 70771147101 ndc11 (package): 70771147203 ndc11 (package): 70771147301 spl id: 9e909702-4471-4cd1-8e97-56b38fba9aa6 spl set id: fcd2ffe2-c8ba-400b-b7f9-e0e4b3510b98

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.