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 10 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer, Orchid Vanilla ScentedALCOHOLFourstar Group USA, Inc.cca1b0ff-f8bd-4440-939e-de3fb7920c2d2026-08-07WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Raspberry White Tea ScentedALCOHOLFourstar Group USA, Inc.c673389a-7154-440f-a1d4-60fe7bcf54f22026-08-07WarningsExact identifier
unii: 3K9958V90M
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
unii: 3K9958V90M
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
unii: 3K9958V90M
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
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact identifier
unii: 3K9958V90M
ALCOHOL WIPEALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD585daf42-ec83-d222-e063-6294a90a83702026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
unii: 3K9958V90M
Uline Hand SanitizerALCOHOLUlinea7aa3bde-d36e-f9d4-e053-2a95a90a6e6a2026-08-06WarningsExact identifier
unii: 3K9958V90M
MagiCare Premium Hand Sanitizing Wipes LavenderALCOHOLMagicare Tech Corp9b66b3bd-1e08-485e-b961-b67a2fcc47512026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Enchanted Rose ScentedALCOHOLFourstar Group USA, Inc.b8216dd0-82e9-411c-b045-d6966a17f18e2026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris ScentedALCOHOLFourstar Group USA, Inc.c5b42ae3-475d-444c-8ff0-784f02ec0ee42026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.143082de-5f48-4229-a39e-fd6aa38acf302026-08-06WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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