FDA.reportPublic FDA data

NDC 61958-0702 - Truvada 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
61958-0702
Package NDCs from labels
61958-0702-2
Manufacturer
Gilead Sciences, Inc
Effective date
2025-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Truvada Access - Gilead Sciences, IncGilead Sciences, Inc2025-07-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-0702-22020-07-22C16284748780-1ab0e2407-3023-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use TRUVADA safely and effectively. See full prescribing information for TRUVADA. TRUVADA™ (emtricitabine and tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-0702-2Truvada Access30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-0702TRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]111 package rows20240711_8bd3debe-d414-450f-b8d9-a70fb1dd5341.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EMTRICITABINEACTIVE INGREDIENTG70B4ETF4STRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
TENOFOVIR DISOPROXIL FUMARATEACTIVE INGREDIENTOTT9J7900ITRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
EMTRICITABINEACTIVE MOIETYG70B4ETF4STRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
TENOFOVIR ANHYDROUSACTIVE MOIETYW4HFE001U5TRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933TRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673TRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC]3
WATERINACTIVE INGREDIENT059QF0KO0RTRUVADA ACCESS (EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM 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 37 of 117 · 2,330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solar Shield TintedTITANIUM DIOXIDE, ZINC OXIDEDENISE BELL SKIN CARE396eb781-5947-3665-e063-6294a90a38dd2025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC3542d8d3-35a3-7d63-e063-6394a90a6fd12025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer non-tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC354357de-1a85-3bdb-e063-6294a90aa9a22025-12-15Exact identifier
unii: 15FIX9V2JP
Mineral Primer tinted SPF40TITANIUM DIOXIDE, ZINC OXIDEOracle Esthetics, LLC35433254-1dc8-a8f3-e063-6394a90a29f02025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357eee3c-1c21-5efb-e063-6294a90a4bb72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357e75ec-473e-df76-e063-6294a90a70c72025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357f2f62-904a-2234-e063-6394a90aee722025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Primer Sunscreen clearTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY357ff025-84ad-6d77-e063-6394a90aad952025-12-15Exact identifier
unii: 15FIX9V2JP
Complexion Correction Tinted Primer SunscreenTITANIUM DIOXIDE, ZINC OXIDEMCRAE MD MEDICAL LASER CENTER, A TEXAS PROFESSIONAL LIMITED LIABILITY COMPANY358021a2-235b-825b-e063-6394a90a76f52025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Physical DefenseTITANIUM DIOXIDE, ZINC OXIDEATLANTA DERMOTOLOGY VEIN & RESEARCH CENTER35477ed2-0875-58d5-e063-6294a90a3d5d2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35a97770-2db9-99aa-e063-6294a90a459a2025-12-15Exact identifier
unii: 15FIX9V2JP
Non-Tinted Sports StickTITANIUM DIOXIDE, ZINC OXIDEHELTON SKIN & LASER INSTITUTE35aa833a-19a1-99e9-e063-6394a90a840f2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Facial PrimerTITANIUM DIOXIDE, ZINC OXIDEBEE NATURALS36c3352e-fa51-19ad-e063-6394a90a591b2025-12-15Exact identifier
unii: 15FIX9V2JP
Velvet Tinted Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a871dc-a707-9963-e063-6294a90a43962025-12-15Exact identifier
unii: 15FIX9V2JP
Velvet NT Moisturizing Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN BOSS L.L.C.35a8508d-7069-c2d6-e063-6394a90a62192025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596fe93-836b-4f8e-e063-6294a90a674a2025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359723bb-6152-9566-e063-6294a90a59e02025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer NTTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC3596cd73-0811-32bc-e063-6394a90ad1322025-12-15Exact identifier
unii: 15FIX9V2JP
Proper Protection Plus Primer TintedTITANIUM DIOXIDE, ZINC OXIDESkin & Proper LLC359782d7-6601-7d96-e063-6394a90af9dc2025-12-15Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEESTHETICS BY RIKI LLC37f1b692-0b80-0536-e063-6294a90ae8632025-12-15Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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