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 4 of 114 · 2,273 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: 3NXW29V3WO
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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