Home NDC 52609-4502-7 FERRIPROX
Product NDC 52609-4502
Requested package NDC 52609-4502-7
11-digit product format 526094502
Labeler code 52609
Product ID 52609-4502_8e4e4a6d-8849-1baf-77ee-90e536bb6b84
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferiprone
Dosage form SOLUTION
Route ORAL
Labeler ApoPharma USA, Inc.
Application NDA208030
Marketing category NDA
Marketing start 2015-09-09
Marketing end 0000-00-00
Substance DEFERIPRONE
Active strength 100 mg/mL
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 · 12 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…
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 N208030-001 FERRIPROX DEFERIPRONE 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 N208030-002 FERRIPROX DEFERIPRONE 80MG/ML SOLUTION / ORAL RLD 2018-04-20
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31
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 · 84 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 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N208030-001 FERRIPROX 100MG/ML SOLUTION / ORAL RLD, RS 2015-09-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N208030-002 FERRIPROX 80MG/ML SOLUTION / ORAL RLD 2018-04-20 bb7c543d1eb4…
Observed Orange Book patent history# Patent history page 1 of 3 · 102 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 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N208030-001 8703156 2029-10-26 U-3083 Drug product 2015-10-06 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N208030-002 8703156 2029-10-26 U-3083 Drug product 2019-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N208030-001 7049328 2021-06-28 U-735 2015-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-001 8703156 2029-10-29 U-735 Drug product 2015-10-06 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-002 7049328 2021-06-28 U-735 2019-01-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N208030-002 8703156 2029-10-29 U-735 Drug product 2019-01-31 74a2ff9319b5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 198 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DEFERIPRONE ACTIVE INGREDIENT 2BTY8KH53L FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 DEFERIPRONE ACTIVE MOIETY 2BTY8KH53L FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Fd&C Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Glycerin INACTIVE INGREDIENT PDC6A3C0OX FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Hydroxyethyl Cellulose (2000 Cps At 1%) INACTIVE INGREDIENT S38J6RZN16 FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Peppermint Oil INACTIVE INGREDIENT AV092KU4JH FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Sucralose INACTIVE INGREDIENT 96K6UQ3ZD4 FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9 Water INACTIVE INGREDIENT 059QF0KO0R FERRIPROX (DEFERIPRONE) SOLUTION [APOPHARMA USA, INC.] 9
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. f057cf4d-b06f-4fbd-aa2e-68c5e4d8a846 2025-05-22 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 208030 application number: NDA208030
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52609-4502-7 52609450207 500 mL in 1 BOTTLE, PLASTIC (52609-4502-7) 500 ml 2015-09-09 0000-00-00 No No Current