Home NDC 70710-1275-3 deferasirox
Product NDC 70710-1275
Requested package NDC 70710-1275-3
11-digit product format 707101275
Labeler code 70710
Product ID 70710-1275_b011a8f6-9341-4dfb-a7cf-eb30cdae32d2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name deferasirox
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA211383
Marketing category ANDA
Marketing start 2019-11-21
Substance DEFERASIROX
Active strength 90 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 43 .
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 A211383-001 DEFERASIROX DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 A211383-002 DEFERASIROX DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 A211383-003 DEFERASIROX DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15
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.
Product history page 1 of 3 · 119 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 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 84e616aacf4f…2026-09-14 22:38:34 2026-08 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211383-002 DEFERASIROX 360MG TABLET / ORAL AB 2019-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211383-003 DEFERASIROX 180MG TABLET / ORAL AB 2020-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211383-001 DEFERASIROX 90MG TABLET / ORAL AB 2019-11-20 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 119 observed states.
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 deferasirox
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEFERASIROX 90 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 1607784 Internal RxNorm lookup 1607792 Internal RxNorm lookup 1607796 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 70710-1275-1 deferasirox 100 in 1 BOTTLE TABLET, FILM COATED 100 12 70710-1275-3 deferasirox 30 in 1 BOTTLE TABLET, FILM COATED 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-1275 DEFERASIROX TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 12 Current NDC, Legacy NDC, 2 package rows 20230725_4af5bc9e-3e09-4dfd-8cc8-7677953c9c7c.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 70710-1275-3 70710127503 30 TABLET, FILM COATED in 1 BOTTLE (70710-1275-3) 2019-11-21 0000-00-00 No No Current