HERNEXEOS

Product NDC: 0597-9257
Requested package NDC: 0597-9257-86
11-digit product format: 005979257
Labeler code: 0597
Product ID: 0597-9257_0fd3e81b-38c9-4d19-b075-9256049a9d41
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: zongertinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: NDA219042
Marketing category: NDA
Marketing start: 2025-08-08
Substance: ZONGERTINIB
Active strength: 60 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], HER2/Neu/cerbB2 Antagonists [MoA], Kinase Inhibitor [EPC]
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 43.

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
N219042-001	HERNEXEOS	ZONGERTINIB	60MG	TABLET / ORAL		RLD, RS	2025-08-08

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
N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25
N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219042-001	NCE	2030-08-08

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
2026-09-14 22:38:34	2026-08	N219042-001	HERNEXEOS	60MG	TABLET / ORAL	RLD, RS	2025-08-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219042-001	HERNEXEOS	60MG	TABLET / ORAL	RLD, RS	2025-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219042-001	HERNEXEOS	60MG	TABLET / ORAL	RLD, RS	2025-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219042-001	HERNEXEOS	60MG	TABLET / ORAL	RLD, RS	2025-08-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219042-001	HERNEXEOS	60MG	TABLET / ORAL	RLD, RS	2025-08-08	`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
2026-09-14 22:38:34	2026-08	N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219042-001	12171739	2026-11-15		Drug substance, Drug product	2025-08-25	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219042-001	11608343	2041-07-21	U-4245	Drug substance, Drug product	2025-08-25	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219042-001	NCE	2030-08-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219042-001	NCE	2030-08-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219042-001	NCE	2030-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219042-001	NCE	2030-08-08	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219042-001	NCE	2030-08-08	`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: HERNEXEOS
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZONGERTINIB	60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DRH7R67UVL	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2721609	Internal RxNorm lookup
2721615	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
d3fabf12-354e-4e5c-b5de-20fdb579b783	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0597-9257-59	HERNEXEOS	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	6
0597-9257-59	HERNEXEOS	1 in 1 CARTON	TABLET, FILM COATED	1	6
0597-9257-86	HERNEXEOS	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	6
0597-9257-86	HERNEXEOS	1 in 1 CARTON	TABLET, FILM COATED	1	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0597-9257-59	EA - Each	0597-9257	e5242c64-1262-4991-a7a2-f1e07b3f6d74	1	2026-02-05
0597-9257-86	EA - Each	0597-9257	12a8466f-fadf-4a05-afb8-ebfa0ad58b7e	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
HERNEXEOS	ZONGERTINIB	Boehringer Ingelheim Pharmaceuticals, Inc.	d3fabf12-354e-4e5c-b5de-20fdb579b783	2026-08-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219042 application number: NDA219042 ndc (package): 0597-9257-86 ndc (product): 0597-9257 ndc11 (package): 00597925786

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2721615	HERNEXEOS 60 MG Oral Tablet	PSN	d3fabf12-354e-4e5c-b5de-20fdb579b783	6
2721609	zongertinib 60 MG Oral Tablet	PSN	d3fabf12-354e-4e5c-b5de-20fdb579b783	6
2721615	zongertinib 60 MG Oral Tablet [Hernexeos]	SBD	d3fabf12-354e-4e5c-b5de-20fdb579b783	6
2721609	zongertinib 60 MG Oral Tablet	SCD	d3fabf12-354e-4e5c-b5de-20fdb579b783	6
2721615	Hernexeos 60 MG Oral Tablet	SY	d3fabf12-354e-4e5c-b5de-20fdb579b783	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0597-9257-86	00597925786	1 BOTTLE, PLASTIC in 1 CARTON (0597-9257-86) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC	2025-08-08	No	No	Current