FDA.reportPublic FDA data

Sunlenca

Product NDC
61958-3001
11-digit product format
619583001
Labeler code
61958
Product ID
61958-3001_12f3f90c-8b72-4e1f-875e-6fcaf4b15959
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LENACAPAVIR SODIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Gilead Sciences, Inc.
Application
NDA215974
Marketing category
NDA
Marketing start
2022-12-22
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LENACAPAVIR SODIUM300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBDT58WJ9WE
Rxcui2625890, 2625896, 2625897, 2625898, 2625899, 2625900, 2625904, 2625909, 2625911, 2625912

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a124dbe4-d4b1-4641-ba1c-c35ad0d241f9Product name120230919

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-3001-1Sunlenca1 in 1 CARTONTABLET, FILM COATED112
61958-3001-1Sunlenca1 in 1 POUCHTABLET, FILM COATED112
61958-3001-2Sunlenca1 in 1 POUCHTABLET, FILM COATED112
61958-3001-2Sunlenca1 in 1 CARTONTABLET, FILM COATED112
61958-3001-3Sunlenca4 in 1 BOTTLE, PLASTICTABLET, FILM COATED412

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-3001-1EA - Each61958-300160cee081-ef98-42a2-a077-481374399a4912023-01-09
61958-3001-2EA - Each61958-3001486ff8ba-9d69-4c55-9c28-ae7b8142afef12023-01-09
61958-3001-3EA - Each61958-3001ac094e0b-9f46-489c-8736-34b0c6e9e5d312025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-3001SUNLENCA (LENACAPAVIR SODIUM) TABLET, FILM COATED SUNLENCA (LENACAPAVIR SODIUM) KIT [GILEAD SCIENCES, INC.]7Current NDC, Legacy NDC, 5 package rows20250406_e5652804-29c4-40d7-aeb2-0142ed2a7b5b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2625912{2 (1.5 ML lenacapavir 309 MG/ML Injection [Sunlenca]) } Pack [Sunlenca 927 MG Kit]BPCKe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625898{4 (lenacapavir 300 MG Oral Tablet [Sunlenca]) } Pack [Sunlenca 4-Tablet Pack]BPCKe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625900{5 (lenacapavir 300 MG Oral Tablet [Sunlenca]) } Pack [Sunlenca 5-Tablet Pack]BPCKe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625911{2 (1.5 ML lenacapavir 309 MG/ML Injection) } PackGPCKe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625897{4 (lenacapavir 300 MG Oral Tablet) } PackGPCKe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625899{5 (lenacapavir 300 MG Oral Tablet) } PackGPCKe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625897lenacapavir 300 MG 4-Tablet PackPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625899lenacapavir 300 MG 5-Tablet PackPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625890lenacapavir 300 MG Oral TabletPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625904lenacapavir 463.5 MG in 1.5 ML InjectionPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625911lenacapavir 927 MG 2-Vial KitPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625896Sunlenca 300 MG Oral TabletPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625898Sunlenca 4-Tablet PackPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625909Sunlenca 463.5 MG in 1.5 ML InjectionPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625900Sunlenca 5-Tablet PackPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625912Sunlenca 927 MG 2-Vial KitPSNe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
26259091.5 ML lenacapavir 309 MG/ML Injection [Sunlenca]SBDe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625896lenacapavir 300 MG Oral Tablet [Sunlenca]SBDe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
26259041.5 ML lenacapavir 309 MG/ML InjectionSCDe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625890lenacapavir 300 MG Oral TabletSCDe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
26259091.5 ML Sunlenca 309 MG/ML InjectionSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625890lenacapavir 300 MG (as lenacapavir sodium 306.8 MG) Oral TabletSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625897lenacapavir 300 MG 4-Tablet PackSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625899lenacapavir 300 MG 5-Tablet PackSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625904lenacapavir 463.5 MG per 1.5 ML InjectionSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625911lenacapavir 927 MG 2-Vial KitSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625896Sunlenca 300 MG Oral TabletSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625898Sunlenca 4-Tablet PackSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625909Sunlenca 463.5 MG per 1.5 ML InjectionSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625900Sunlenca 5-Tablet PackSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12
2625912Sunlenca 927 MG 2-Vial KitSYe5652804-29c4-40d7-aeb2-0142ed2a7b5b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61958-3001-1619583001011 POUCH in 1 CARTON (61958-3001-1) / 1 BLISTER PACK in 1 POUCH / 4 TABLET, FILM COATED in 1 BLISTER PACK1 pouch2022-12-220000-00-00NoNoCurrent
61958-3001-2619583001021 POUCH in 1 CARTON (61958-3001-2) / 1 BLISTER PACK in 1 POUCH / 5 TABLET, FILM COATED in 1 BLISTER PACK1 pouch2022-12-220000-00-00NoNoCurrent
61958-3001-3619583001034 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-3001-3) 2024-11-13NoNoCurrent