Deferasirox Tablets for Oral Suspension

Manufacturer
Zydus Lifesciences Limited
Effective date
2024-11-28
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:48:25

Label at a glance#

ProductDEFERASIROX
Active ingredientDEFERASIROX
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1409-3

Deferasirox Tablets for Oral Suspension, 125 mg

30 Tablets

Rx only

125 mg label
125 mg label

NDC 70771-1410-3

Deferasirox Tablets for Oral Suspension, 250 mg

30 Tablets

Rx only

250 mg label
250 mg label

NDC 70771-1411-3

Deferasirox Tablets for Oral Suspension, 500 mg

30 Tablets

Rx only

500 mg label
500 mg label

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208882-001DEFERASIROXDEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05
A208882-002DEFERASIROXDEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05
A208882-003DEFERASIROXDEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-0584e616aacf4f…
2026-09-14 22:38:342026-08A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-0584e616aacf4f…
2026-09-14 22:38:342026-08A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-0584e616aacf4f…
2026-08-18 06:07:402026-07A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05caaa826d4ba7…
2026-08-18 06:07:402026-07A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208882-002DEFERASIROX250MGTABLET, FOR SUSPENSION / ORAL2020-05-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208882-003DEFERASIROX500MGTABLET, FOR SUSPENSION / ORAL2020-05-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208882-001DEFERASIROX125MGTABLET, FOR SUSPENSION / ORAL2020-05-05301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2020-11-12 02:37 UTC2020-11A208882-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A208882-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A208882-003AB1c0c555d07b60…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
df7ed729-6bf1-4a08-8bbd-5cf5f46c50458df9bad9-0be5-4dc1-b16d-8a1e8727d45c2025-04-07Exact identifier
spl set id: 8df9bad9-0be5-4dc1-b16d-8a1e8727d45c

Reported adverse events (FAERS/openFDA)#

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