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 43 of 117 · 2,330 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
unii: 15FIX9V2JP
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
unii: 15FIX9V2JP
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
unii: 15FIX9V2JP
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
unii: 15FIX9V2JP
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
unii: 15FIX9V2JP
SPF 40 Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.35081ce0-2203-ab86-e063-6294a90aefd52025-12-11Exact identifier
unii: 15FIX9V2JP
Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDETeton Dermatology Holdings, Inc.3509eea7-f966-2080-e063-6294a90aeeb52025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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