Home NDC 72647-372 Deferasirox Oral Granules
Product NDC 72647-372
11-digit product format 726470372
Labeler code 72647
Product ID 72647-372_b170a73b-628d-4c59-b837-768812fbdd6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferasirox
Dosage form GRANULE
Route ORAL
Labeler OAKRUM PHARMA, LLC
Application ANDA214559
Marketing category ANDA
Marketing start 2021-03-09
Marketing end 2024-01-31
Substance DEFERASIROX
Active strength 180 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 0000-00-00
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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 72647-372-30 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 72647-372-30 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 72647-372-30 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 72647-372-30 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 72647-372-30 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 72647-372-30 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 72647-372-30 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 72647-372-30 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 72647-372-30 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 72647-372-30 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 72647-372-30 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 72647-372-30 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 A214559-001 DEFERASIROX DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 A214559-002 DEFERASIROX DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 A214559-003 DEFERASIROX DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09
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 · 102 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 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214559-002 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214559-003 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214559-001 DEFERASIROX 90MG GRANULE / ORAL AB 2021-03-09 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 102 observed states.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72647-372-30 72647037230 30 PACKET in 1 CARTON (72647-372-30) > 1 GRANULE in 1 PACKET 30 packet 2021-03-09 2024-01-31 No No Current