HYRNUO

Product NDC: 50419-397
Requested package NDC: 50419-397-01
11-digit product format: 504190397
Labeler code: 50419
Product ID: 50419-397_2ba86679-0db2-44b4-86d1-e69413e24762
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SEVABERTINIB
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bayer HealthCare Pharmaceuticals Inc.
Application: NDA219972
Marketing category: NDA
Marketing start: 2025-11-19
Substance: SEVABERTINIB
Active strength: 10 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 44.

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
N219972-001	HYRNUO	SEVABERTINIB	10MG	TABLET / ORAL		RLD, RS	2025-11-19

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09
N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219972-001	NCE	2030-11-19

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
2026-10-15 13:18:30	2026-09	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219972-001	HYRNUO	10MG	TABLET / ORAL	RLD, RS	2025-11-19	`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
2026-10-15 13:18:30	2026-09	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219972-001	12679836	2043-11-14	U-4582	Drug substance, Drug product	2026-08-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219972-001	10428063	2036-01-25		Drug substance, Drug product	2025-12-09	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219972-001	10428063	2035-10-10		Drug substance, Drug product	2025-12-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N219972-001	NCE	2030-11-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219972-001	NCE	2030-11-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219972-001	NCE	2030-11-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219972-001	NCE	2030-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219972-001	NCE	2030-11-19	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219972-001	NCE	2030-11-19	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEVABERTINIB	10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50419-397-01	HYRNUO	120 in 1 BOTTLE	TABLET, FILM COATED	120		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-397-01	EA - Each	50419-397	d35cc56d-5bd4-4056-8d40-5356ec502f67	1	2025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2728198	HYRNUO 10 MG Oral Tablet	PSN	d7a11334-6e7a-445b-9a16-bdcd9acbe61f	8
2728192	sevabertinib 10 MG Oral Tablet	PSN	d7a11334-6e7a-445b-9a16-bdcd9acbe61f	8
2728198	sevabertinib 10 MG Oral Tablet [Hyrnuo]	SBD	d7a11334-6e7a-445b-9a16-bdcd9acbe61f	8
2728192	sevabertinib 10 MG Oral Tablet	SCD	d7a11334-6e7a-445b-9a16-bdcd9acbe61f	8
2728198	Hyrnuo 10 MG Oral Tablet	SY	d7a11334-6e7a-445b-9a16-bdcd9acbe61f	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
50419-397-01	50419039701	120 TABLET, FILM COATED in 1 BOTTLE (50419-397-01)	2025-11-19	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HYRNUO	Bayer HealthCare Pharmaceuticals Inc. \| Bayer AG \| Sharp Corporation	2026-09-17	HUMAN PRESCRIPTION DRUG LABEL	10