FDA.reportPublic FDA data

Yeztugo

Product NDC
61958-3402
11-digit product format
619583402
Labeler code
61958
Product ID
61958-3402_557388f0-4c3d-4fee-9bc8-72b035775b2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LENACAPAVIR SODIUM
Dosage form
KIT
Labeler
Gilead Sciences, Inc.
Application
NDA220018
Marketing category
NDA
Marketing start
2025-06-18
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N220018-001YEZTUGOLENACAPAVIR SODIUMEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-18

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11
N220018-001100719852037-08-17Drug substance, Drug product2025-07-11
N220018-001112677992038-08-16Drug substance2025-07-11
N220018-001125942672039-07-15Drug product2026-04-16
N220018-001118076252040-11-25U-41902025-07-11

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N220018-001NCE2027-12-22
N220018-001NP2028-06-18

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-1884e616aacf4f…
2026-08-18 06:07:402026-07N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001YEZTUGOEQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)SOLUTION / SUBCUTANEOUSRLD, RS2025-06-18a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N220018-001100719852037-08-17Drug substance, Drug product2025-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N220018-001112677992038-08-16Drug substance2025-07-1184e616aacf4f…
2026-09-14 22:38:342026-08N220018-001125942672039-07-15Drug product2026-04-1684e616aacf4f…
2026-09-14 22:38:342026-08N220018-001118076252040-11-25U-41902025-07-1184e616aacf4f…
2026-08-18 06:07:402026-07N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N220018-001100719852037-08-17Drug substance, Drug product2025-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N220018-001112677992038-08-16Drug substance2025-07-11caaa826d4ba7…
2026-08-18 06:07:402026-07N220018-001125942672039-07-15Drug product2026-04-16caaa826d4ba7…
2026-08-18 06:07:402026-07N220018-001118076252040-11-25U-41902025-07-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001100719852037-08-17Drug substance, Drug product2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001112677992038-08-16Drug substance2025-07-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001118076252040-11-25U-41902025-07-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001100719852037-08-17Drug substance, Drug product2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001112677992038-08-16Drug substance2025-07-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001118076252040-11-25U-41902025-07-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001100719852037-08-17Drug substance, Drug product2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001112677992038-08-16Drug substance2025-07-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001118076252040-11-25U-41902025-07-116a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-00199510432034-02-28U-4190Drug substance, Drug product2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001100719852037-08-17Drug substance, Drug product2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001112677992038-08-16Drug substance2025-07-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001125942672039-07-15Drug product2026-04-16a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001118076252040-11-25U-41902025-07-11a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N220018-001NCE2027-12-2284e616aacf4f…
2026-09-14 22:38:342026-08N220018-001NP2028-06-1884e616aacf4f…
2026-08-18 06:07:402026-07N220018-001NCE2027-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N220018-001NP2028-06-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N220018-001NCE2027-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N220018-001NP2028-06-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001NCE2027-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N220018-001NP2028-06-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08N220018-001NCE2027-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N220018-001NP2028-06-186a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001NCE2027-12-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N220018-001NP2028-06-18a50c72e98297…

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BDT58WJ9WEInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2625890Internal RxNorm lookup
2625904Internal RxNorm lookup
2625911Internal RxNorm lookup
2717197Internal RxNorm lookup
2717201Internal RxNorm lookup
2717203Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1c241af1-ce62-4b0a-9eb7-f6b626174f01Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a124dbe4-d4b1-4641-ba1c-c35ad0d241f9Product name120230919
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-3402-1Yeztugo1 in 1 CARTONKIT14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-3402-1ML - Milliliter61958-34020010a8fa-8bf0-412a-9ea0-e5b51801e1dc12025-07-08

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YeztugoLENACAPAVIR SODIUMGilead Sciences, Inc.1c241af1-ce62-4b0a-9eb7-f6b626174f012026-08-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 220018
application number: NDA220018
ndc (product): 61958-3402

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717203{2 (1.5 ML lenacapavir 309 MG/ML Injection [Yeztugo]) } Pack [Yeztugo 927 MG Kit]BPCK1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625911{2 (1.5 ML lenacapavir 309 MG/ML Injection) } PackGPCK1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625890lenacapavir 300 MG Oral TabletPSN1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625904lenacapavir 463.5 MG in 1.5 ML InjectionPSN1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625911lenacapavir 927 MG 2-Vial KitPSN1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717197Yeztugo 300 MG Oral TabletPSN1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717201Yeztugo 463.5 MG in 1.5 ML InjectionPSN1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717203Yeztugo 927 MG 2-Vial KitPSN1c241af1-ce62-4b0a-9eb7-f6b626174f014
27172011.5 ML lenacapavir 309 MG/ML Injection [Yeztugo]SBD1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717197lenacapavir 300 MG Oral Tablet [Yeztugo]SBD1c241af1-ce62-4b0a-9eb7-f6b626174f014
26259041.5 ML lenacapavir 309 MG/ML InjectionSCD1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625890lenacapavir 300 MG Oral TabletSCD1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625890lenacapavir 300 MG (as lenacapavir sodium 306.8 MG) Oral TabletSY1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625904lenacapavir 463.5 MG per 1.5 ML InjectionSY1c241af1-ce62-4b0a-9eb7-f6b626174f014
2625911lenacapavir 927 MG 2-Vial KitSY1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717197Yeztugo 300 MG (as lenacapavir sodium 306.8 MG) Oral TabletSY1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717201Yeztugo 463.5 MG per 1.5 ML InjectionSY1c241af1-ce62-4b0a-9eb7-f6b626174f014
2717203Yeztugo 927 MG 2-Vial KitSY1c241af1-ce62-4b0a-9eb7-f6b626174f014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61958-3402-1619583402011 KIT in 1 CARTON (61958-3402-1) * 1.5 mL in 1 VIAL (61958-3403-1) 1 kit2025-06-18NoNoCurrent