FDA.reportPublic FDA data

NDC 61958-0402 - Viread Access

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
61958-0402
Package NDCs from labels
61958-0402-3, 61958-0402-6
Manufacturer
Gilead Sciences, Inc.
Effective date
2026-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Viread Access - Gilead Sciences, Inc.Gilead Sciences, Inc.2026-02-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-0402-32025-01-30C16284748780-12cef2736-5967-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. GILEAD ACCESS PROGRAM VIREAD™ (tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2001
61958-0402-62025-01-30C16284748780-12cef2736-5967-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. GILEAD ACCESS PROGRAM VIREAD™ (tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2001
61958-0402-72025-01-30C16284748780-12cef2736-5967-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use VIREAD safely and effectively. See full prescribing information for VIREAD. GILEAD ACCESS PROGRAM VIREAD™ (tenofovir disoproxil fumarate) tablets, for oral use Initial U.S. Approval: 2001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0402-3Viread Access30 in 1 BOTTLE, PLASTICTABLET, COATED3011
61958-0402-6Viread Access30 in 1 BOTTLE, PLASTICTABLET, COATED3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0402VIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC]92 package rows20210316_1fdae465-2c01-4030-a73c-fd2f13368453.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TENOFOVIR DISOPROXIL FUMARATEACTIVE INGREDIENTOTT9J7900IVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
TENOFOVIR ANHYDROUSACTIVE MOIETYW4HFE001U5VIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673VIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RVIREAD ACCESS (TENOFOVIR DISOPROXIL FUMARATE) TABLET, COATED [GILEAD SCIENCES, INC.]3

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 · 2,273 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: OTT9J7900I
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
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
Tenofovir Disoproxil FumarateTENOFOVIR DISOPROXIL FUMARATEBryant Ranch Prepacke0ae0aa2-3baa-4b75-9e85-68b5338c3c142026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349251
unii: OTT9J7900I
DELSTRIGODORAVIRINE, LAMIVUDINE, AND TENOFOVIR DISOPROXIL FUMARATEMerck Sharp & Dohme LLCcd1e9f84-607a-46d3-b01e-2736018d67b62026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: OTT9J7900I
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

Reported adverse events (FAERS/openFDA)#

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