MODEYSO

Product NDC: 68727-250
11-digit product format: 687270250
Labeler code: 68727
Product ID: 68727-250_9d57dcc7-fa17-4ecf-ada1-3a4b1cf92032
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: dordaviprone
Dosage form: CAPSULE
Route: ORAL
Labeler: Jazz Pharmaceuticals, Inc.
Application: NDA219876
Marketing category: NDA
Marketing start: 2025-08-06
Substance: DORDAVIPRONE
Active strength: 125 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219876-001	MODEYSO	DORDAVIPRONE HYDROCHLORIDE	EQ 125MG BASE	CAPSULE / ORAL		RLD, RS	2025-08-06

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219876-001	9629842	2032-04-30	U-4254		2025-09-03
N219876-001	RE46290	2032-04-30	U-4254		2025-09-03
N219876-001	9265765	2034-07-26		Drug product	2025-09-03
N219876-001	11976068	2036-03-01		Drug product	2025-09-03
N219876-001	10172862	2037-01-30	U-4254		2025-09-03
N219876-001	10369154	2037-01-30	U-4254		2025-09-03
N219876-001	12102639	2037-01-30	U-4254		2025-09-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219876-001	NCE	2030-08-06
N219876-001	ODE-547	2032-08-06

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
2026-08-18 06:07:40	2026-07	N219876-001	MODEYSO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2025-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219876-001	MODEYSO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2025-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	MODEYSO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2025-08-06	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	MODEYSO	EQ 125MG BASE	CAPSULE / ORAL	RLD, RS	2025-08-06	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N219876-001	9629842	2032-04-30	U-4254		2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	RE46290	2032-04-30	U-4254		2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	9265765	2034-07-26		Drug product	2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	11976068	2036-03-01		Drug product	2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	10172862	2037-01-30	U-4254		2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	10369154	2037-01-30	U-4254		2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	12102639	2037-01-30	U-4254		2025-09-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219876-001	9629842	2032-04-30	U-4254		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219876-001	RE46290	2032-04-30	U-4254		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219876-001	9265765	2034-07-26		Drug product	2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219876-001	11976068	2036-03-01		Drug product	2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219876-001	10172862	2037-01-30	U-4254		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219876-001	10369154	2037-01-30	U-4254		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219876-001	12102639	2037-01-30	U-4254		2025-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	9629842	2032-04-30	U-4254		2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	RE46290	2032-04-30	U-4254		2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	9265765	2034-07-26		Drug product	2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	11976068	2036-03-01		Drug product	2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	10172862	2037-01-30	U-4254		2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	10369154	2037-01-30	U-4254		2025-09-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	12102639	2037-01-30	U-4254		2025-09-03	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	9629842	2032-04-30	U-4254		2025-09-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	RE46290	2032-04-30	U-4254		2025-09-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	9265765	2034-07-26		Drug product	2025-09-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	11976068	2036-03-01		Drug product	2025-09-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	10172862	2037-01-30	U-4254		2025-09-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	10369154	2037-01-30	U-4254		2025-09-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	12102639	2037-01-30	U-4254		2025-09-03	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N219876-001	NCE	2030-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219876-001	ODE-547	2032-08-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219876-001	NCE	2030-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219876-001	NCE	2030-08-06	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	NCE	2030-08-06	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219876-001	ODE-547	2032-08-06	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: MODEYSO
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DORDAVIPRONE	125 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9U35A31JAI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2721199	Internal RxNorm lookup
2721205	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
ad45b43e-fdef-47ad-9c34-055b41bdc576	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68727-250-01	MODEYSO	1 in 1 CARTON	CAPSULE	1		2
68727-250-01	MODEYSO	10 in 1 BOTTLE	CAPSULE	10		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68727-250-01	EA - Each	68727-250	dff18d25-d139-4c82-92e7-6edaa67de0c2	1	2025-09-12

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
MODEYSO	DORDAVIPRONE	Jazz Pharmaceuticals, Inc.	ad45b43e-fdef-47ad-9c34-055b41bdc576	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219876 application number: NDA219876 ndc (product): 68727-250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2721199	dordaviprone 125 MG Oral Capsule	PSN	ad45b43e-fdef-47ad-9c34-055b41bdc576	2
2721205	MODEYSO 125 MG Oral Capsule	PSN	ad45b43e-fdef-47ad-9c34-055b41bdc576	2
2721205	dordaviprone 125 MG Oral Capsule [Modeyso]	SBD	ad45b43e-fdef-47ad-9c34-055b41bdc576	2
2721199	dordaviprone 125 MG Oral Capsule	SCD	ad45b43e-fdef-47ad-9c34-055b41bdc576	2
2721199	dordaviprone 125 MG (equivalent to dordaviprone hydrochloride 148.8 MG) Oral Capsule	SY	ad45b43e-fdef-47ad-9c34-055b41bdc576	2
2721205	Modeyso 125 MG (equivalent to dordaviprone hydrochloride 148.8 MG) Oral Capsule	SY	ad45b43e-fdef-47ad-9c34-055b41bdc576	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68727-250-01	68727025001	1 BOTTLE in 1 CARTON (68727-250-01) / 10 CAPSULE in 1 BOTTLE	1 bottle	2025-08-06	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
MODEYSO	Jazz Pharmaceuticals, Inc. \| API, Inc. \| Robertson Microlit Laboratories, Inc. \| Frontida BioPharm, LLC \| Frontage Laboratories, Inc.	2026-01-09	HUMAN PRESCRIPTION DRUG LABEL	2