Home NDC 10122-103 FERRIPROX
Product NDC 10122-103
11-digit product format 101220103
Labeler code 10122
Product ID 10122-103_f6d7984f-011e-4a3f-bcf5-6a5b2b6ef2f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEFERIPRONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chiesi USA, Inc.
Application NDA021825
Marketing category NDA
Marketing start 2019-08-01
Substance DEFERIPRONE
Active strength 1000 mg/1
Pharmacologic classes Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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.
Additional Listing Data#
Finished product Yes
Brand name base FERRIPROX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFERIPRONE 1000 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2BTY8KH53L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 389242 Internal RxNorm lookup 1190357 Internal RxNorm lookup 2180997 Internal RxNorm lookup 2180999 Internal RxNorm lookup 2685014 Internal RxNorm lookup 2685015 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10122-103-05 FERRIPROX 50 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 50 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10122-103 FERRIPROX (DEFERIPRONE) TABLET FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [CHIESI USA, INC.] 13 Current NDC, Legacy NDC, 1 package rows 20250417_946718ff-df43-1baa-74d1-e5bcfbe8ad86.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.
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 10122-103-05 10122010305 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10122-103-05) 2019-08-01 0000-00-00 No No Current