Home NDC 69539-303-30 Deferasorox
Product NDC 69539-303
Requested package NDC 69539-303-30
11-digit product format 695390303
Labeler code 69539
Product ID 69539-303_40154b92-b71c-4ccc-b959-99b5c1528d25
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Deferasirox
Dosage form GRANULE
Route ORAL
Labeler MSN LABORATORIES PRIVATE LIMITED
Application ANDA214650
Marketing category ANDA
Marketing start 2022-04-29
Marketing end 0000-00-00
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 2023-12-31
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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 69539-303 69539-303-30 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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 A214650-001 DEFERASIROX DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 A214650-002 DEFERASIROX DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 A214650-003 DEFERASIROX DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20
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 · 103 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 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 84e616aacf4f…2026-09-14 22:38:34 2026-08 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 84e616aacf4f…2026-08-18 06:07:40 2026-07 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214650-002 DEFERASIROX 360MG GRANULE / ORAL AB 2021-03-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214650-003 DEFERASIROX 90MG GRANULE / ORAL AB 2022-04-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214650-001 DEFERASIROX 180MG GRANULE / ORAL AB 2021-03-17 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 103 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69539-303 DEFERASOROX (DEFERASIROX) GRANULE [MSN LABORATORIES PRIVATE LIMITED] 2 Legacy NDC 20220503_97a62d3d-b910-4d2d-abf6-19ffa33e7005.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Deferasorox DEFERASIROX Novadoz Pharmaceuticals LLC 1122f1c0-c160-49db-a31b-90d7521370f5 2022-05-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 214650 application number: ANDA214650
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69539-303-30 69539030330 30 PACKET in 1 CARTON (69539-303-30) > 1 GRANULE in 1 PACKET (69539-303-62) 30 packet 2022-04-29 0000-00-00 No No Current