Home NDC 0054-0711 Deferiprone
Product NDC 0054-0711
11-digit product format 000540711
Labeler code 0054
Product ID 0054-0711_db72caee-70a3-4561-b855-08b4c9f4a0e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deferiprone
Dosage form TABLET, COATED
Route ORAL
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA213239
Marketing category ANDA
Marketing start 2022-02-08
Substance DEFERIPRONE
Active strength 1000 mg/1
Pharmacologic classes Iron Chelating Activity [MoA], Iron Chelator [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 A213239-001 DEFERIPRONE DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 A213239-002 DEFERIPRONE DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08
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 · 68 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 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB RS 2022-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB 2022-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB 2022-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB 2022-02-08 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213239-002 DEFERIPRONE 1GM TABLET / ORAL AB 2022-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A213239-001 DEFERIPRONE 500MG TABLET / ORAL AB 2021-03-29 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Deferiprone
Listing expiration 2026-12-31 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2180997 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 0054-0711-19 Deferiprone 50 in 1 BOTTLE TABLET, COATED 50 3 0054-0711-23 Deferiprone 150 in 1 BOTTLE TABLET, COATED 150 3 0054-0711-28 Deferiprone 300 in 1 BOTTLE TABLET, COATED 300 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0054-0711 DEFERIPRONE TABLET, COATED [HIKMA PHARMACEUTICALS USA INC.] 2 Current NDC, Legacy NDC, 3 package rows 20230912_c4f9e9be-39e7-4940-9cb0-f17772d7e524.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 · 2 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 0054-0711-19 00054071119 50 TABLET, COATED in 1 BOTTLE (0054-0711-19) 2022-02-08 0000-00-00 No No Current 0054-0711-23 00054071123 150 TABLET, COATED in 1 BOTTLE (0054-0711-23) 2022-02-08 0000-00-00 No No Current 0054-0711-28 00054071128 300 TABLET, COATED in 1 BOTTLE (0054-0711-28) 2022-02-08 0000-00-00 No No Current