Home NDC 59651-449 DEFERASIROX
Product NDC 59651-449
11-digit product format 596510449
Labeler code 59651
Product ID 59651-449_c220484e-1e6a-4a0c-a221-60223f3bc24c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DEFERASIROX
Dosage form GRANULE
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA215137
Marketing category ANDA
Marketing start 2025-09-08
Substance DEFERASIROX
Active strength 360 mg/1
Pharmacologic classes Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], 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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A215137-001 DEFERASIROX DEFERASIROX 90MG GRANULE / ORAL AB 2025-09-08 A215137-002 DEFERASIROX DEFERASIROX 180MG GRANULE / ORAL AB 2025-09-08 A215137-003 DEFERASIROX DEFERASIROX 360MG GRANULE / ORAL AB 2025-09-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 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.
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 2026-02-19 14:30 UTC 2026-02 A215137-001 DEFERASIROX 90MG GRANULE / ORAL AB 2025-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215137-002 DEFERASIROX 180MG GRANULE / ORAL AB 2025-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A215137-003 DEFERASIROX 360MG GRANULE / ORAL AB 2025-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215137-001 DEFERASIROX 90MG GRANULE / ORAL AB 2025-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215137-002 DEFERASIROX 180MG GRANULE / ORAL AB 2025-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215137-003 DEFERASIROX 360MG GRANULE / ORAL AB 2025-09-08 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215137-001 DEFERASIROX 90MG GRANULE / ORAL AB 2025-09-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215137-002 DEFERASIROX 180MG GRANULE / ORAL AB 2025-09-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215137-003 DEFERASIROX 360MG GRANULE / ORAL AB 2025-09-08 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base DEFERASIROX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFERASIROX 360 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination V8G4MOF2V9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1923822 Internal RxNorm lookup 1923826 Internal RxNorm lookup 1923828 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 59651-449-30 DEFERASIROX 30 in 1 CARTON GRANULE 30 1 59651-449-54 DEFERASIROX 1 in 1 PACKET GRANULE 1 1
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 Sample Exclude flag Status 59651-449-30 59651044930 30 PACKET in 1 CARTON (59651-449-30) / 1 GRANULE in 1 PACKET (59651-449-54) 30 packet 2025-09-08 No No Current 59651-449-54 59651044954 1 in 1 PACKET Historical