Isturisa

Product NDC: 55292-322
Requested package NDC: 55292-322-20
11-digit product format: 552920322
Labeler code: 55292
Product ID: 55292-322_06e491a0-5048-424a-9fa3-5109679d7908
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: 0000-00-00
Substance: OSILODROSTAT PHOSPHATE
Active strength: 10 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
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	55292-322	55292-322-20	D	Discontinued by firm		2026-08-11

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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	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.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212801-001	ODE-286	2027-03-06
N212801-001	ODE-535	2032-04-15
N212801-002	ODE-286	2027-03-06
N212801-002	ODE-535	2032-04-15
N212801-003	ODE-286	2027-03-06
N212801-003	ODE-535	2032-04-15

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N212801-001	ODE-286	2027-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212801-002	ODE-286	2027-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212801-003	ODE-286	2027-03-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-001	NCE	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-001	ODE-286	2027-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-002	NCE	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-002	ODE-286	2027-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-003	NCE	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212801-003	ODE-286	2027-03-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212801-001	NCE	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-001	ODE-286	2027-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-002	NCE	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-002	ODE-286	2027-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-003	NCE	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212801-003	ODE-286	2027-03-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	NCE	2025-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-001	ODE-286	2027-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	NCE	2025-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-002	ODE-286	2027-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	NCE	2025-03-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212801-003	ODE-286	2027-03-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	NCE	2025-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-001	ODE-286	2027-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	NCE	2025-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-002	ODE-286	2027-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	NCE	2025-03-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212801-003	ODE-286	2027-03-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-001	NCE	2025-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-001	ODE-286	2027-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-002	NCE	2025-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-002	ODE-286	2027-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-003	NCE	2025-03-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212801-003	ODE-286	2027-03-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212801-001	NCE	2025-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212801-001	ODE-286	2027-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212801-002	NCE	2025-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212801-002	ODE-286	2027-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212801-003	NCE	2025-03-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212801-003	ODE-286	2027-03-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212801-001	NCE	2025-03-06	`5bbf6a4d5a75…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e84c7901-5467-4923-8689-3c818af16a20	Product name	1	20200416
b24d4793-65b6-4af9-9458-71c74807c5cb	Product name	1	20200330

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55292-322-20	Isturisa	20 in 1 BLISTER PACK	TABLET, COATED	20		10
55292-322-60	Isturisa	60 in 1 BLISTER PACK	TABLET, COATED	60		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55292-322-20	EA - Each	55292-322	6ee0f7a9-4372-411a-8452-fd60e670ac58	1	2020-05-08
55292-322-60	EA - Each	55292-322	f822646d-be0d-4b23-b30f-47abec1412d4	1	2020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55292-322	ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED ISTURISA (OSILODROSTAT) TABLET, COATED [RECORDATI RARE DISEASES, INC.]	7	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Isturisa	OSILODROSTAT	Recordati Rare Diseases, Inc.	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212801 application number: NDA212801 ndc (package): 55292-322-20 ndc (product): 55292-322 ndc11 (package): 55292032220

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Y6581YAW9V	OSILODROSTAT PHOSPHATE	1315449-72-9	OSILODROSTAT PHOSPHATE
5YL4IQ1078	OSILODROSTAT	928134-65-0	Osilodrostat

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2286281	Isturisa 1 MG Oral Tablet	PSN	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286285	Isturisa 10 MG Oral Tablet	PSN	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286290	Isturisa 5 MG Oral Tablet	PSN	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286275	osilodrostat 1 MG Oral Tablet	PSN	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286283	osilodrostat 10 MG Oral Tablet	PSN	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286288	osilodrostat 5 MG Oral Tablet	PSN	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286281	osilodrostat 1 MG Oral Tablet [Isturisa]	SBD	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286285	osilodrostat 10 MG Oral Tablet [Isturisa]	SBD	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286290	osilodrostat 5 MG Oral Tablet [Isturisa]	SBD	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286275	osilodrostat 1 MG Oral Tablet	SCD	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286283	osilodrostat 10 MG Oral Tablet	SCD	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286288	osilodrostat 5 MG Oral Tablet	SCD	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286281	Isturisa 1 MG (as osilodrostat phosphate 1.4 MG) Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286281	Isturisa 1 MG Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286285	Isturisa 10 MG (as osilodrostat phosphate 14.3 MG) Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286285	Isturisa 10 MG Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286290	Isturisa 5 MG (as osilodrostat phosphate 7.2 MG) Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286290	Isturisa 5 MG Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286275	osilodrostat 1 MG (as osilodrostat phosphate 1.4 MG) Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286283	osilodrostat 10 MG (as osilodrostat phosphate 14.3 MG) Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10
2286288	osilodrostat 5 MG (as osilodrostat phosphate 7.2 MG) Oral Tablet	SY	f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55292-322-20	55292032220	20 TABLET, COATED in 1 BLISTER PACK (55292-322-20)	2020-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Isturisa	Recordati Rare Diseases, Inc. \| Novartis Pharma Stein AG	2025-11-18	HUMAN PRESCRIPTION DRUG LABEL	10