FDA.reportPublic FDA data

NDC 61958-1901-01 - Genvoya

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
61958-1901
Requested NDC
61958-1901-01
Package NDCs from labels
61958-1901-1, 61958-1901-01
Manufacturer
REMEDYREPACK INC.
Effective date
2025-02-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Genvoya - REMEDYREPACK INC.REMEDYREPACK INC.2025-02-14HUMAN PRESCRIPTION DRUG LABEL
Genvoya - Gilead Sciences, Inc.Gilead Sciences, Inc.2025-02-03HUMAN PRESCRIPTION DRUG LABEL
Genvoya - A-S Medication SolutionsA-S Medication Solutions2018-01-10HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-1901-12020-07-22C16284748780-1ab0e2407-2ab2-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use GENVOYA safely and effectively. See full prescribing information for GENVOYA. GENVOYA ® (elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets, for oral use Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1901-1Genvoya30 in 1 BOTTLE, PLASTICTABLET3022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1901GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE) TABLET [GILEAD SCIENCES, INC.]22Current NDC, Legacy NDC, 1 package rows20250205_34784acf-15ed-4715-b504-eb30430518e9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-1901-1EA - Each61958-1901d979311b-fa08-420f-87fd-7a300cdacc6312015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cobicistatACTIVE INGREDIENTLW2E03M5PGGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
elvitegravirACTIVE INGREDIENT4GDQ854U53GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
emtricitabineACTIVE INGREDIENTG70B4ETF4SGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
tenofovir alafenamide fumarateACTIVE INGREDIENTFWF6Q91TZOGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
cobicistatACTIVE MOIETYLW2E03M5PGGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
elvitegravirACTIVE MOIETY4GDQ854U53GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
emtricitabineACTIVE MOIETYG70B4ETF4SGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
tenofovir alafenamideACTIVE MOIETYEL9943AG5JGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990GENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RGENVOYA (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE) TABLET [GILEAD SCIENCES, INC.]1

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 2 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions41bd03ea-b92e-459c-968b-c9095ae90aef2026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: G70B4ETF4S
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: 532B59J990
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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