Home NDC 52609-0007 FERRIPROX
Product NDC 52609-0007
11-digit product format 526090007
Labeler code 52609
Product ID 52609-0007_b02c7ef0-b683-ea13-bcb4-30be2a740fd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferiprone
Dosage form TABLET, FILM COATED
Route ORAL
Labeler ApoPharma USA, Inc.
Application NDA021825
Marketing category NDA
Marketing start 2019-08-01
Marketing end 0000-00-00
Substance DEFERIPRONE
Active strength 1000 mg/1
Pharmacologic classes Iron Chelating Activity [MoA],Iron Chelator [EPC]
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 · 30 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 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 52609-0007-5 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 52609-0007-5 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 52609-0007-5 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 52609-0007-5 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021825-001 FERRIPROX DEFERIPRONE 500MG TABLET / ORAL RLD 2011-10-14 N021825-002 FERRIPROX DEFERIPRONE 1GM TABLET / ORAL AB RLD 2019-07-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021825-002 AB
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 · 83 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 2026-08-18 06:07:40 2026-07 N021825-001 FERRIPROX 500MG TABLET / ORAL RLD 2011-10-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD 2011-10-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021825-001 FERRIPROX 500MG TABLET / ORAL RLD, RS 2011-10-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021825-002 FERRIPROX 1GM TABLET / ORAL RLD 2019-07-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021825-001 FERRIPROX 500MG TABLET / ORAL AB RLD, RS 2011-10-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021825-001 7049328 2021-06-28 U-735 2015-10-08 74a2ff9319b5…2021-12-28 21:50 UTC 2021-12 N021825-001 7049328 2021-06-28 U-3083 2015-10-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021825-002 7049328 2021-06-28 U-3083 2020-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021825-001 7049328 2021-06-28 U-735 2015-10-08 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021825-002 7049328 2021-06-28 U-735 2020-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021825-001 7049328 2021-06-28 U-735 2015-10-08 5aa47cf7b7d7…2021-03-12 10:30 UTC 2021-03 N021825-002 7049328 2021-06-28 U-735 2020-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021825-001 7049328 2021-06-28 U-735 2015-10-08 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021825-002 7049328 2021-06-28 U-735 2020-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021825-001 7049328 2021-06-28 U-735 2015-10-08 c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021825-002 7049328 2021-06-28 U-735 2020-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021825-001 7049328 2021-06-28 U-735 2015-10-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021825-001 7049328 2021-06-28 U-735 2015-10-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021825-001 7049328 2021-06-28 U-735 2015-10-08 ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 198 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 52609-0007-5 FERRIPROX 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52609-0007 FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 Legacy NDC, 1 package rows 20200305_57bd50e6-c948-0037-4a4b-c8951f70d04a.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FERRIPROX DEFERIPRONE Chiesi USA, Inc. 946718ff-df43-1baa-74d1-e5bcfbe8ad86 2026-01-28 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021825 application number: NDA021825
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 52609-0007-5 52609000705 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52609-0007-5) 2019-08-01 0000-00-00 No No Current