FDA.reportPublic FDA data

NDC 61958-3001-01 - Sunlenca

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
61958-3001
Requested NDC
61958-3001-01
Package NDCs from labels
61958-3001-1, 61958-3001-2, 61958-3001-3, 61958-3001-01
Manufacturer
Gilead Sciences, Inc.
Effective date
2026-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sunlenca - Gilead Sciences, Inc.Gilead Sciences, Inc.2026-08-27HUMAN PRESCRIPTION DRUG LABEL

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 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 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

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 115 · 2,291 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: 532B59J990
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SunlencaLENACAPAVIR SODIUMGilead Sciences, Inc.e5652804-29c4-40d7-aeb2-0142ed2a7b5b2026-08-27Warnings, Adverse reactionsExact identifier
application number: NDA215974
application number: NDA215973
ndc (package): 61958-3005-1
ndc (package): 61958-3001-3
ndc (package): 61958-3004-1
ndc (package): 61958-3001-2
ndc (package): 61958-3001-1
ndc (package): 61958-3002-1
ndc (product): 61958-3005
ndc (product): 61958-3001
ndc (product): 61958-3002
ndc11 (package): 61958300101
rxcui: 2625899
rxcui: 2625897
rxcui: 2625890
rxcui: 2625909
rxcui: 2625904
rxcui: 2625900
rxcui: 2625911
rxcui: 2625896
rxcui: 2625912
rxcui: 2625898
spl id: 142b440e-6eae-4d76-8312-b094de1380c3
spl set id: e5652804-29c4-40d7-aeb2-0142ed2a7b5b
unii: BDT58WJ9WE
BIXLENVOBICTEGRAVIR/LENACAPAVIRGilead Sciences, Inc.072a3c7e-33fb-4a87-ba21-3d8dad3f5c482026-08-27Warnings, Adverse reactionsExact identifier
unii: BDT58WJ9WE
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.