Home NDC 69238-1704 deferasirox
Product NDC 69238-1704
11-digit product format 692381704
Labeler code 69238
Product ID 69238-1704_30a9b4e3-6d26-43b3-87ba-855df34c9e8d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferasirox
Dosage form GRANULE
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA214194
Marketing category ANDA
Marketing start 2021-02-09
Marketing end 0000-00-00
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 2023-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 69238-1704 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69238-1704 69238-1704-3 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 RLD / RS Approval date A214194-001 DEFERASIROX DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 A214194-002 DEFERASIROX DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 A214194-003 DEFERASIROX DEFERASIROX 90MG GRANULE / ORAL 2021-08-02
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 · 109 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 2026-09-14 22:38:34 2026-08 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214194-002 DEFERASIROX 360MG GRANULE / ORAL 2021-02-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214194-003 DEFERASIROX 90MG GRANULE / ORAL 2021-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214194-001 DEFERASIROX 180MG GRANULE / ORAL 2021-02-09 301d65b070ca…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69238-1704 DEFERASIROX GRANULE [AMNEAL PHARMACEUTICALS NY LLC] 14 Legacy NDC 20231230_19f4b412-3d35-4e31-80b6-f13d26c300c5.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69238-1704-1 69238170401 1 GRANULE in 1 PACKET (69238-1704-1) 1 granule 2021-02-09 0000-00-00 No No Current 69238-1704-3 69238170403 30 GRANULE in 1 CARTON (69238-1704-3) 30 granule 2021-02-09 0000-00-00 No No Current