PALSONIFY

Product NDC: 84015-920
Requested package NDC: 84015-920-60
11-digit product format: 840150920
Labeler code: 84015
Product ID: 84015-920_73db4875-9ff1-4eaf-bc83-0e494aada598
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PALTUSOTINE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Crinetics Pharmaceuticals, Inc.
Application: NDA219070
Marketing category: NDA
Marketing start: 2025-09-25
Substance: PALTUSOTINE HYDROCHLORIDE
Active strength: 20 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219070-001	PALSONIFY	PALTUSOTINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL		RLD	2025-09-25
N219070-002	PALSONIFY	PALTUSOTINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL		RLD, RS	2025-09-25

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
N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	10875839	2037-07-12	U-4283		2025-10-21
N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-001	10464918	2039-01-16		Drug substance	2025-10-21
N219070-001	11266641	2041-09-07	U-4283	Drug product	2025-10-21
N219070-001	11957674	2041-09-07	U-4283		2025-10-21
N219070-001	12208092	2044-03-25	U-4282		2025-10-21
N219070-002	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	10875839	2037-07-12	U-4283		2025-10-21
N219070-002	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21
N219070-002	10464918	2039-01-16		Drug substance	2025-10-21
N219070-002	11266641	2041-09-07	U-4283	Drug product	2025-10-21
N219070-002	11957674	2041-09-07	U-4283		2025-10-21
N219070-002	12208092	2044-03-25	U-4282		2025-10-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219070-001	NCE	2030-09-25
N219070-001	ODE-537	2032-09-25
N219070-002	NCE	2030-09-25
N219070-002	ODE-537	2032-09-25

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	PALSONIFY	EQ 20MG BASE	TABLET / ORAL	RLD	2025-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-002	PALSONIFY	EQ 30MG BASE	TABLET / ORAL	RLD, RS	2025-09-25	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 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	N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	10875839	2037-07-12	U-4283		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	10464918	2039-01-16		Drug substance	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	11957674	2041-09-07	U-4283		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-001	12208092	2044-03-25	U-4282		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	10875839	2037-07-12	U-4283		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	10464918	2039-01-16		Drug substance	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	11957674	2041-09-07	U-4283		2025-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	12208092	2044-03-25	U-4282		2025-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	10875839	2037-07-12	U-4283		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	10464918	2039-01-16		Drug substance	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	11957674	2041-09-07	U-4283		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	12208092	2044-03-25	U-4282		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	10875839	2037-07-12	U-4283		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	9896432	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	10464918	2039-01-16		Drug substance	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	11266641	2041-09-07	U-4283	Drug product	2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	11957674	2041-09-07	U-4283		2025-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	12208092	2044-03-25	U-4282		2025-10-21	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	10351547	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	10597377	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	10875839	2037-07-12	U-4283		2025-10-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	11414397	2037-07-12	U-4283	Drug substance, Drug product	2025-10-21	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219070-001	NCE	2030-09-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219070-002	NCE	2030-09-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-001	NCE	2030-09-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219070-002	NCE	2030-09-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	NCE	2030-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-001	ODE-537	2032-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-002	NCE	2030-09-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219070-002	ODE-537	2032-09-25	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: PALSONIFY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PALTUSOTINE HYDROCHLORIDE	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FZT5Z83JNS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2724403	Internal RxNorm lookup
2724409	Internal RxNorm lookup
2724411	Internal RxNorm lookup
2724413	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8a6d2ce0-a621-4ee7-983c-977cd948ff4d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84015-920-60	PALSONIFY	60 in 1 BOTTLE	TABLET, FILM COATED	60		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84015-920-60	EA - Each	84015-920	dcf87104-ac9e-4d66-91d6-8e1e2b13747d	1	2025-10-14

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
PALSONIFY	PALTUSOTINE	Crinetics Pharmaceuticals, Inc.	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	2025-09-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219070 application number: NDA219070 ndc (package): 84015-920-60 ndc (product): 84015-920 ndc11 (package): 84015092060

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2724409	Palsonify 20 MG Oral Tablet, Once Daily	PSN	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724413	Palsonify 30 MG Oral Tablet, Once Daily	PSN	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724403	paltusotine 20 MG Oral Tablet, Once Daily	PSN	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724411	paltusotine 30 MG Oral Tablet, Once Daily	PSN	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724409	paltusotine 20 MG Oral Tablet [Palsonify]	SBD	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724413	paltusotine 30 MG Oral Tablet [Palsonify]	SBD	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724403	paltusotine 20 MG Oral Tablet	SCD	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724411	paltusotine 30 MG Oral Tablet	SCD	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724409	Palsonify 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet	SY	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724409	Palsonify 20 MG Oral Tablet	SY	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724413	Palsonify 30 MG (equivalent to paltusotine hydrochloride 32.4 MG) Oral Tablet	SY	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724413	Palsonify 30 MG Oral Tablet	SY	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724403	paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet	SY	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3
2724411	paltusotine 30 MG (equivalent to paltusotine hydrochloride 32.4 MG) Oral Tablet	SY	8a6d2ce0-a621-4ee7-983c-977cd948ff4d	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
84015-920-60	84015092060	60 TABLET, FILM COATED in 1 BOTTLE (84015-920-60)	2025-09-25	No	No	Current