FDA.reportPublic FDA data

NDC 61958-1802 - Harvoni 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
61958-1802
Package NDCs from labels
61958-1802-6
Manufacturer
Gilead Sciences, Inc
Effective date
2025-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Harvoni Access - Gilead Sciences, IncGilead Sciences, Inc2025-06-16HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-1802-62025-06-20C16284748780-12cef2736-72b0-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014
61958-1802-62025-01-30C16284748780-12cef2736-72b0-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1802-6Harvoni Access28 in 1 BOTTLE, PLASTICTABLET, FILM COATED2810

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1802HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]91 package rows20210701_1a1c555d-2fdf-4150-8ace-dbc770c226bf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEDIPASVIRACTIVE INGREDIENT013TE6E4WVHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
SOFOSBUVIRACTIVE INGREDIENTWJ6CA3ZU8BHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
LEDIPASVIRACTIVE MOIETY013TE6E4WVHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
SOFOSBUVIRACTIVE MOIETYWJ6CA3ZU8BHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]1
WATERINACTIVE INGREDIENT059QF0KO0RHARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [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 42 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tru Skin Rituals SPF 25TITANIUM DIOXIDE, ZINC OXIDESpa de Soleilf725cd5c-999e-2393-e053-6394a90a09dc2026-04-30WarningsExact identifier
unii: 15FIX9V2JP
meijer APPLE SCENTED Hand SanitizerETHYL ALCOHOLMeijer, Inc.502e471d-fe0a-1d82-e063-6294a90a376d2026-04-30WarningsExact identifier
unii: 3K9958V90M
Hydrate ICOFFEA TOSTA, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.c0c8d350-0257-4484-acd8-f852350173db2026-04-30WarningsExact identifier
unii: ETJ7Z6XBU4
Ethyl Rubbing AlcoholETHYL ALCOHOLYour Military Exchanges3dce175c-f893-4cfc-b495-6c11f2b77b872026-04-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509cad98-0321-2a0a-e063-6294a90a6ea92026-04-29WarningsExact identifier
unii: 15FIX9V2JP
Summit 375 Gel Alcohol Hand SanitizerALCOHOLR.L. Williams Company509cc442-09f8-d17f-e063-6394a90a77ea2026-04-29WarningsExact identifier
unii: 3K9958V90M
Ethyl AlcoholETHYL ALCOHOLWalmart Inc.1fd3bed0-8fcc-2cee-e063-6294a90a34fb2026-04-29Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
TiZO2TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.509d7206-0cc1-c997-e063-6294a90a89e02026-04-29WarningsExact identifier
unii: 15FIX9V2JP
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.50949ae2-3ebe-08d2-e063-6394a90a20462026-04-29WarningsExact identifier
unii: 3K9958V90M
MHB SKIN HYDRATING HAND SANITIZER SANTAL WAVE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.493120ee-0c5c-b704-e063-6394a90a8c192026-04-29WarningsExact identifier
unii: 3K9958V90M
JMSOLUTION SKIN BOOST NIACINAMIDE SUNSCREENHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEGPNY CORP211dea04-faad-8ffc-e063-6294a90a8d682026-04-29WarningsExact identifier
unii: 15FIX9V2JP
B-Pure Moisturizing Hand Sanitizer Vanilla Creme ScentedALCOHOLFourstar Group USA, Inc.13faded0-7953-4d86-b952-e4bcf4ba53cc2026-04-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Sweet Plum and Jasmine ScentedALCOHOLFourstar Group USA, Inc.450d025a-cc11-796e-e063-6394a90a7e5c2026-04-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Hand Sanitizer Coconut Vanilla ScentedALCOHOLFourstar Group USA, Inc.e179b21d-fb93-4671-87c0-b8ae094533282026-04-28WarningsExact identifier
unii: 3K9958V90M
Anything SPFOCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDEAnything SPF LLC508b8dcb-6600-6dad-e063-6294a90a565a2026-04-28WarningsExact identifier
unii: 15FIX9V2JP
Scriptsusa Hand SanitizerALCOHOLEnergized Solution Corp4f97edd9-717a-315b-e063-6394a90aade72026-04-27WarningsExact identifier
unii: 3K9958V90M
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
unii: 3K9958V90M
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLMerchSource, LLC5054a055-50d0-f12a-e063-6294a90ad78e2026-04-25WarningsExact identifier
unii: 3K9958V90M
Ethyl AlcoholETHYL ALCOHOLUpLift Brands, LLC5035ec52-2d65-cbbf-e063-6294a90a4a5c2026-04-24Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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