Home NDC 10122-104 FERRIPROX
Product NDC 10122-104
11-digit product format 101220104
Labeler code 10122
Product ID 10122-104_f6d7984f-011e-4a3f-bcf5-6a5b2b6ef2f9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferiprone
Dosage form TABLET
Route ORAL
Labeler Chiesi USA, Inc.
Application NDA212269
Marketing category NDA
Marketing start 2020-05-19
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212269-001 FERRIPROX DEFERIPRONE 1GM TABLET / ORAL RLD, RS 2020-05-19
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 N212269-001 11723874 2038-10-25 U-3083 2023-09-14
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N212269-001 ODE-417 2028-04-30 N212269-001 ODE-420 2028-04-30 N212269-001 ODE-421 2028-04-30
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.
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 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212269-001 FERRIPROX 1GM TABLET / ORAL RLD, RS 2020-05-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 189 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 11458103 2038-10-25 Drug product 2022-10-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212269-001 11723874 2038-10-25 U-3083 2023-09-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 10780055 2038-10-25 U-3083 Drug product 2020-10-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 10940115 2038-10-25 U-3083 Drug product 2021-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 10940116 2038-10-25 Drug product 2021-03-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212269-001 11357731 2038-10-25 U-3083 2022-06-21 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 99 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 10122-104-01 FERRIPROX 50 in 1 BLISTER PACK TABLET 50 15 10122-104-05 FERRIPROX 50 in 1 BOTTLE, PLASTIC TABLET 50 15
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10122-104 FERRIPROX (DEFERIPRONE) TABLET FERRIPROX (DEFERIPRONE) TABLET, FILM COATED [CHIESI USA, INC.] 13 Current NDC, Legacy NDC, 2 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 Units Marketing start Marketing end Sample Exclude flag Status 10122-104-01 10122010401 50 TABLET in 1 BLISTER PACK (10122-104-01) 50 tablet 2020-05-19 0000-00-00 No No Current 10122-104-05 10122010405 50 TABLET in 1 BOTTLE, PLASTIC (10122-104-05) 50 tablet 2021-12-01 0000-00-00 No No Current