Home NDC 55292-320 Isturisa
Product NDC 55292-320
11-digit product format 552920320
Labeler code 55292
Product ID 55292-320_5c1e5bfa-9d7b-4a4a-b030-caf7bb57c6df
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name osilodrostat
Dosage form TABLET, COATED
Route ORAL
Labeler Recordati Rare Diseases, Inc.
Application NDA212801
Marketing category NDA
Marketing start 2020-03-31
Marketing end 2029-12-31
Substance OSILODROSTAT PHOSPHATE
Active strength 1 mg/1
Pharmacologic classes Cortisol Synthesis Inhibitor [EPC], Cytochrome P450 11B1 Inhibitors [MoA], Cytochrome P450 1A2 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Cytochrome P450 3A5 Inhibitors [MoA]
NDC exclude flag No
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 N212801-001 ISTURISA OSILODROSTAT PHOSPHATE EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 N212801-002 ISTURISA OSILODROSTAT PHOSPHATE EQ 5MG BASE TABLET / ORAL RLD, RS 2020-03-06 N212801-003 ISTURISA OSILODROSTAT PHOSPHATE EQ 10MG BASE TABLET / ORAL RLD 2020-03-06
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212801-001 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 N212801-001 8609862 2031-01-13 U-4529 2020-04-03 N212801-001 9434754 2031-01-13 Drug substance 2020-04-03 N212801-001 8314097 2033-05-20 Drug substance, Drug product 2020-04-03 N212801-001 10143680 2035-07-06 Drug product 2020-04-03 N212801-001 10709691 2035-10-12 U-4529 2020-08-06 N212801-002 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 N212801-002 8609862 2031-01-13 U-4529 2020-04-03 N212801-002 9434754 2031-01-13 Drug substance 2020-04-03 N212801-002 8314097 2033-05-20 Drug substance, Drug product 2020-04-03 N212801-002 10143680 2035-07-06 Drug product 2020-04-03 N212801-002 10709691 2035-10-12 U-4529 2020-08-06 N212801-003 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 N212801-003 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 N212801-003 8609862 2031-01-13 U-2770 2020-04-03 N212801-003 9434754 2031-01-13 Drug substance 2020-04-03 N212801-003 10143680 2035-07-06 Drug product 2020-04-03 N212801-003 10709691 2035-10-12 U-2770 2020-08-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 · 111 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 2026-02-19 14:30 UTC 2026-02 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212801-002 ISTURISA EQ 5MG BASE TABLET / ORAL RLD 2020-03-06 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212801-003 ISTURISA EQ 10MG BASE TABLET / ORAL RLD 2020-03-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212801-001 ISTURISA EQ 1MG BASE TABLET / ORAL RLD 2020-03-06 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 17 · 678 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N212801-001 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 8609862 2031-01-13 U-4177 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 8609862 2031-01-13 U-2770 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 9434754 2031-01-13 Drug substance 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 10143680 2035-07-06 Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 10709691 2035-10-12 U-4177 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-001 10709691 2035-10-12 U-2770 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8609862 2031-01-13 U-4177 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 8609862 2031-01-13 U-2770 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 9434754 2031-01-13 Drug substance 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 10143680 2035-07-06 Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 10709691 2035-10-12 U-4177 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-002 10709691 2035-10-12 U-2770 2020-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 8609862 2031-01-13 U-2770 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 9434754 2031-01-13 Drug substance 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 10143680 2035-07-06 Drug product 2020-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212801-003 10709691 2035-10-12 U-2770 2020-08-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8609862 2031-01-13 U-4177 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 8609862 2031-01-13 U-2770 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 9434754 2031-01-13 Drug substance 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 10143680 2035-07-06 Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 10709691 2035-10-12 U-4177 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-001 10709691 2035-10-12 U-2770 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8609862 2031-01-13 U-4177 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 8609862 2031-01-13 U-2770 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 9434754 2031-01-13 Drug substance 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 10143680 2035-07-06 Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 10709691 2035-10-12 U-4177 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-002 10709691 2035-10-12 U-2770 2020-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-003 8835646 2026-08-23 Drug substance, Drug product 2020-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212801-003 8314097 2029-03-27 Drug substance, Drug product 2020-04-03 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 219 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Isturisa Active Ingredients# Ingredient, Strength table Ingredient Strength OSILODROSTAT PHOSPHATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Y6581YAW9V Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2286275 Internal RxNorm lookup 2286281 Internal RxNorm lookup 2286283 Internal RxNorm lookup 2286285 Internal RxNorm lookup 2286288 Internal RxNorm lookup 2286290 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 55292-320-20 Isturisa 20 in 1 BLISTER PACK TABLET, COATED 20 10 55292-320-60 Isturisa 60 in 1 BLISTER PACK TABLET, COATED 60 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55292-320 ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED [RECORDATI RARE DISEASES, INC.] 7 Current NDC, Legacy NDC, 2 package rows 20250430_f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2.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.
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 55292-320-20 55292032020 20 TABLET, COATED in 1 BLISTER PACK (55292-320-20) 2020-03-31 2029-12-31 No No Current 55292-320-60 55292032060 60 TABLET, COATED in 1 BLISTER PACK (55292-320-60) 2020-03-31 2029-12-31 No No Current