Home NDC 0591-3853-30 Deferasirox
Product NDC 0591-3853
Requested package NDC 0591-3853-30
11-digit product format 005913853
Labeler code 0591
Product ID 0591-3853_dc305bb9-31ee-4cee-8f19-04b0593f4bf4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deferasirox
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA208697
Marketing category ANDA
Marketing start 2019-12-17
Marketing end 0000-00-00
Substance DEFERASIROX
Active strength 180 mg/1
Pharmacologic classes Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A208697-001 DEFERASIROX DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 A208697-002 DEFERASIROX DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 A208697-003 DEFERASIROX DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13
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 3 · 111 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 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208697-002 DEFERASIROX 180MG TABLET / ORAL AB 2019-12-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208697-003 DEFERASIROX 360MG TABLET / ORAL AB 2019-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208697-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-12-13 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 111 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2020-12-22 03:56 UTC 2020-12 A208697-002 PC 2020-06-14 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208697-002 PC 2020-06-14 c0c555d07b60…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0591-3853-30 00591385330 30 TABLET, FILM COATED in 1 BOTTLE (0591-3853-30) 2019-12-17 0000-00-00 No No Current