Home NDC 70710-1012 DEFERASIROX
Product NDC 70710-1012
11-digit product format 707101012
Labeler code 70710
Product ID 70710-1012_3e05f5bd-bd51-485f-97dd-5817d3f37658
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEFERASIROX
Dosage form TABLET, FOR SUSPENSION
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA208882
Marketing category ANDA
Marketing start 2021-05-06
Marketing end 0000-00-00
Substance DEFERASIROX
Active strength 250 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 · 8 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 70710-1012-1 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70710-1012-9 d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70710-1012-3 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 70710-1012-1 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70710-1012-9 f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 70710-1012-3 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 A208882-001 DEFERASIROX DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 A208882-002 DEFERASIROX DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 A208882-003 DEFERASIROX DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05
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 2 of 3 · 120 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 2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL AB 2020-05-05 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL AB 2020-05-05 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 A208882-003 DEFERASIROX 500MG TABLET, FOR SUSPENSION / ORAL AB 2020-05-05 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208882-001 DEFERASIROX 125MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208882-002 DEFERASIROX 250MG TABLET, FOR SUSPENSION / ORAL 2020-05-05 6a51e52b5d6a…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 70710-1012-1 70710101201 100 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-1) 2021-05-06 0000-00-00 No No Current 70710-1012-3 70710101203 30 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-3) 2021-05-06 0000-00-00 No No Current 70710-1012-9 70710101209 90 TABLET, FOR SUSPENSION in 1 BOTTLE (70710-1012-9) 2021-05-06 0000-00-00 No No Current