Yeztugo

Product NDC: 61958-3401
11-digit product format: 619583401
Labeler code: 61958
Product ID: 61958-3401_557388f0-4c3d-4fee-9bc8-72b035775b2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LENACAPAVIR SODIUM
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Gilead Sciences, Inc.
Application: NDA220020
Marketing category: NDA
Marketing start: 2025-06-18
Substance: LENACAPAVIR SODIUM
Active strength: 300 mg/1
Pharmacologic classes: Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 3A Inhibitors [MoA], HIV Capsid Inhibitors [MoA], Human Immunodeficiency Virus 1 Capsid Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA]
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
N220020-001	YEZTUGO	LENACAPAVIR SODIUM	EQ 300MG BASE	TABLET / ORAL		RLD, RS	2025-06-18

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11
N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11
N220020-001	11267799	2038-08-16		Drug substance	2025-07-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N220020-001	NCE	2027-12-22
N220020-001	NP	2028-06-18

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	N220020-001	YEZTUGO	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2025-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220020-001	YEZTUGO	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2025-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N220020-001	YEZTUGO	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2025-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220020-001	YEZTUGO	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2025-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N220020-001	YEZTUGO	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2025-06-18	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220020-001	YEZTUGO	EQ 300MG BASE	TABLET / ORAL	RLD, RS	2025-06-18	`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	N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220020-001	11267799	2038-08-16		Drug substance	2025-07-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220020-001	11267799	2038-08-16		Drug substance	2025-07-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220020-001	11267799	2038-08-16		Drug substance	2025-07-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220020-001	11267799	2038-08-16		Drug substance	2025-07-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220020-001	11267799	2038-08-16		Drug substance	2025-07-11	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220020-001	9951043	2034-02-28	U-4190	Drug substance, Drug product	2025-07-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220020-001	10071985	2037-08-17		Drug substance, Drug product	2025-07-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220020-001	11267799	2038-08-16		Drug substance	2025-07-11	`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	N220020-001	NCE	2027-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N220020-001	NP	2028-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N220020-001	NCE	2027-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N220020-001	NP	2028-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N220020-001	NCE	2027-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N220020-001	NP	2028-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220020-001	NCE	2027-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N220020-001	NP	2028-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N220020-001	NCE	2027-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N220020-001	NP	2028-06-18	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220020-001	NCE	2027-12-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N220020-001	NP	2028-06-18	`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: Yeztugo
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LENACAPAVIR SODIUM	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
BDT58WJ9WE	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2625890	Internal RxNorm lookup
2625904	Internal RxNorm lookup
2625911	Internal RxNorm lookup
2717197	Internal RxNorm lookup
2717201	Internal RxNorm lookup
2717203	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
1c241af1-ce62-4b0a-9eb7-f6b626174f01	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a124dbe4-d4b1-4641-ba1c-c35ad0d241f9	Product name	1	20230919
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-3401-1	Yeztugo	4 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	4		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-3401-1	EA - Each	61958-3401	c8799ed0-8649-405f-a048-5f5e735ce55a	1	2025-07-08

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
Yeztugo	LENACAPAVIR SODIUM	Gilead Sciences, Inc.	1c241af1-ce62-4b0a-9eb7-f6b626174f01	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 220020 application number: NDA220020 ndc (product): 61958-3401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2717203	{2 (1.5 ML lenacapavir 309 MG/ML Injection [Yeztugo]) } Pack [Yeztugo 927 MG Kit]	BPCK	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625911	{2 (1.5 ML lenacapavir 309 MG/ML Injection) } Pack	GPCK	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625890	lenacapavir 300 MG Oral Tablet	PSN	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625904	lenacapavir 463.5 MG in 1.5 ML Injection	PSN	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625911	lenacapavir 927 MG 2-Vial Kit	PSN	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717197	Yeztugo 300 MG Oral Tablet	PSN	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717201	Yeztugo 463.5 MG in 1.5 ML Injection	PSN	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717203	Yeztugo 927 MG 2-Vial Kit	PSN	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717201	1.5 ML lenacapavir 309 MG/ML Injection [Yeztugo]	SBD	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717197	lenacapavir 300 MG Oral Tablet [Yeztugo]	SBD	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625904	1.5 ML lenacapavir 309 MG/ML Injection	SCD	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625890	lenacapavir 300 MG Oral Tablet	SCD	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625890	lenacapavir 300 MG (as lenacapavir sodium 306.8 MG) Oral Tablet	SY	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625904	lenacapavir 463.5 MG per 1.5 ML Injection	SY	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2625911	lenacapavir 927 MG 2-Vial Kit	SY	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717197	Yeztugo 300 MG (as lenacapavir sodium 306.8 MG) Oral Tablet	SY	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717201	Yeztugo 463.5 MG per 1.5 ML Injection	SY	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4
2717203	Yeztugo 927 MG 2-Vial Kit	SY	1c241af1-ce62-4b0a-9eb7-f6b626174f01	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
61958-3401-1	61958340101	4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3401-1)	2025-06-18	No	No	Current