Home NDC 59651-412 DEFERASIROX
Product NDC 59651-412
11-digit product format 596510412
Labeler code 59651
Product ID 59651-412_3b584d19-7a28-43b4-86db-756caf83709a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEFERASIROX
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA214474
Marketing category ANDA
Marketing start 2023-10-16
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 A214474-001 DEFERASIROX DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 A214474-002 DEFERASIROX DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 A214474-003 DEFERASIROX DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 2 · 57 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 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214474-002 DEFERASIROX 180MG TABLET / ORAL AB 2023-10-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214474-003 DEFERASIROX 360MG TABLET / ORAL AB 2023-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214474-001 DEFERASIROX 90MG TABLET / ORAL AB 2023-10-16 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 57 observed states.
Additional Listing Data#
Finished product Yes
Brand name base DEFERASIROX
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1607784 Internal RxNorm lookup 1607792 Internal RxNorm lookup 1607796 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-412-30 DEFERASIROX 30 in 1 BOTTLE TABLET, FILM COATED 30 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-412 DEFERASIROX TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 3 Current NDC, 1 package rows 20240511_c7f14819-1abc-4abf-b55b-cf89beaf124e.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-412-30 59651041230 30 TABLET, FILM COATED in 1 BOTTLE (59651-412-30) 2023-10-16 No No Current