Home NDC 52609-0006-1 FERRIPROX
Product NDC 52609-0006
Requested package NDC 52609-0006-1
11-digit product format 526090006
Labeler code 52609
Product ID 52609-0006_e6670b22-0237-7289-57fe-5cc612b842f9
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 2011-11-25
Marketing end 0000-00-00
Substance DEFERIPRONE
Active strength 500 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 · 15 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…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 85 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 N021825-001 FERRIPROX 500MG TABLET / ORAL RLD 2011-10-14 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021825-002 FERRIPROX 1GM TABLET / ORAL AB RLD 2019-07-25 84e616aacf4f…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 67 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 6 · 204 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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 52609-0006-1 FERRIPROX 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEFERIPRONE ACTIVE INGREDIENT 2BTY8KH53L FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 DEFERIPRONE ACTIVE MOIETY 2BTY8KH53L FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 HYPROMELLOSE 2910 (15000 MPA.S) INACTIVE INGREDIENT 288VBX44JC FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 POLYETHYLENE GLYCOL 3350 INACTIVE INGREDIENT G2M7P15E5P FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 52609-0006 FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [APOPHARMA USA, INC.] 7 Legacy NDC, 1 package rows 20200305_dc8cbc3d-026c-0db5-42e8-8e93d374dd23.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 52609-0006-1 52609000601 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (52609-0006-1) 2011-11-25 0000-00-00 No No Current