Home NDC 73190-095 Deferiprone
Product NDC 73190-095
11-digit product format 731900095
Labeler code 73190
Product ID 73190-095_58dd1379-c90d-d871-e063-6294a90a174c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deferiprone
Dosage form TABLET
Route ORAL
Labeler AvKARE
Application ANDA208800
Marketing category ANDA
Marketing start 2026-08-12
Substance DEFERIPRONE
Active strength 500 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 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 A208800-001 DEFERIPRONE DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 A208800-002 DEFERIPRONE DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 2 · 63 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 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208800-002 DEFERIPRONE 1GM TABLET / ORAL AB 2023-11-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL 2019-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208800-001 DEFERIPRONE 500MG TABLET / ORAL AB 2019-02-08 5aa47cf7b7d7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 59 observed states.
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A208800-001 PC 2021-03-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208800-001 PC 2021-03-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208800-001 PC 2021-03-27 5aa47cf7b7d7…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Deferiprone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFERIPRONE 500 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 389242 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 73190-095-01 73190009501 100 TABLET in 1 BOTTLE (73190-095-01) 100 tablet 2026-08-12 No No Current