VEPPANU

Product NDC: 84043-100
11-digit product format: 840430100
Labeler code: 84043
Product ID: 84043-100_35775ae7-f00d-1c21-e063-6294a90a914c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: vepdegestrant
Dosage form: TABLET
Route: ORAL
Labeler: Arvinas Operations, Inc.
Application: NDA219835
Marketing category: NDA
Marketing start: 2026-05-01
Substance: VEPDEGESTRANT
Active strength: 100 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 43.

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
N219835-001	VEPPANU	VEPDEGESTRANT	100MG	TABLET / ORAL		RLD	2026-05-01
N219835-002	VEPPANU	VEPDEGESTRANT	200MG	TABLET / ORAL		RLD, RS	2026-05-01

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219835-001	10899742	2037-12-01	U-4278		2026-05-29
N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29
N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29
N219835-002	10899742	2037-12-01	U-4278		2026-05-29
N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29
N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219835-001	NCE	2031-05-01
N219835-002	NCE	2031-05-01

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	N219835-001	VEPPANU	100MG	TABLET / ORAL	RLD	2026-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	VEPPANU	200MG	TABLET / ORAL	RLD, RS	2026-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219835-001	VEPPANU	100MG	TABLET / ORAL	RLD	2026-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	VEPPANU	200MG	TABLET / ORAL	RLD, RS	2026-05-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	VEPPANU	100MG	TABLET / ORAL	RLD	2026-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	VEPPANU	200MG	TABLET / ORAL	RLD, RS	2026-05-01	`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	N219835-001	10899742	2037-12-01	U-4278		2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	10899742	2037-12-01	U-4278		2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219835-001	10899742	2037-12-01	U-4278		2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	10899742	2037-12-01	U-4278		2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	10899742	2037-12-01	U-4278		2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	10899742	2037-12-01	U-4278		2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	11597720	2037-12-01	U-4278	Drug substance, Drug product	2026-05-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	10647698	2038-01-30		Drug substance, Drug product	2026-05-29	`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	N219835-001	NCE	2031-05-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219835-002	NCE	2031-05-01	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219835-001	NCE	2031-05-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219835-002	NCE	2031-05-01	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-001	NCE	2031-05-01	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219835-002	NCE	2031-05-01	`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: VEPPANU
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VEPDEGESTRANT	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WC1U3R1YMI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2743355	Internal RxNorm lookup
2743361	Internal RxNorm lookup
2743363	Internal RxNorm lookup
2743365	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
751e18d5-1d41-4b67-b1f3-10272ca5312d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84043-100-30	VEPPANU	30 in 1 BOTTLE	TABLET	30		2

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VEPPANU	VEPDEGESTRANT	Rigel Pharmaceuticals, Inc.	484e21ba-8fe1-4c6d-b923-8ba4cf5b2f20	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219835 application number: NDA219835
VEPPANU	VEPDEGESTRANT	Arvinas Operations, Inc.	751e18d5-1d41-4b67-b1f3-10272ca5312d	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219835 application number: NDA219835 ndc (product): 84043-100

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2743355	vepdegestrant 100 MG Oral Tablet	PSN	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743363	vepdegestrant 200 MG Oral Tablet	PSN	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743361	VEPPANU 100 MG Oral Tablet	PSN	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743365	VEPPANU 200 MG Oral Tablet	PSN	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743361	vepdegestrant 100 MG Oral Tablet [Veppanu]	SBD	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743365	vepdegestrant 200 MG Oral Tablet [Veppanu]	SBD	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743355	vepdegestrant 100 MG Oral Tablet	SCD	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743363	vepdegestrant 200 MG Oral Tablet	SCD	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743361	Veppanu 100 MG Oral Tablet	SY	751e18d5-1d41-4b67-b1f3-10272ca5312d	2
2743365	Veppanu 200 MG Oral Tablet	SY	751e18d5-1d41-4b67-b1f3-10272ca5312d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84043-100-30	84043010030	30 TABLET in 1 BOTTLE (84043-100-30)	30 tablet	2026-05-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VEPPANU	Arvinas Operations, Inc. \| Pfizer Manufacturing Deutschland GmbH \| Sharp Packaging Services, LLC	2025-05-01	HUMAN PRESCRIPTION DRUG LABEL	2