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 33 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
vanilla sugar hand sanitizer gelALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd567c99e6-3bc8-0600-e063-6294a90a94c92026-06-01WarningsExact identifier
unii: 3K9958V90M
very berry hand sanitizer gelALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd567d6ce2-59fa-01ae-e063-6394a90a9e782026-06-01WarningsExact identifier
unii: 3K9958V90M
Smart Care WHISPERING WOODS HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.dce079a4-3984-4258-82f8-7e90da31e12c2026-05-29WarningsExact identifier
unii: 3K9958V90M
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREENTITANIUM DIOXIDE AND ZINC OXIDELOreal USA Products Inc294e6049-12b5-4b45-ae00-8ee1d9d2a1a42026-05-29WarningsExact identifier
unii: 15FIX9V2JP
ProCure Foaming Hand SanitizerETHYL ALCOHOL 72%Twin Med LLC3d848ec8-5197-6d39-e063-6394a90aaef62026-05-29WarningsExact identifier
unii: 3K9958V90M
Smart Care MEADOW MIRAGE HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.3157d8d9-35ac-4157-b97d-4cc2b6bd812e2026-05-29WarningsExact identifier
unii: 3K9958V90M
Smart Care MIDNIGHT MUSK HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.4a9d80b7-619a-4eba-9535-ea7605b6cd712026-05-29WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerETHYL ALCOHOLZhejiang Gaorong Cosmetic Co., Ltd.52db71d5-42fc-c3b6-e063-6394a90aea152026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Creamy Macadamia ScentedALCOHOLFourstar Group USA, Inc.e59282f1-82f1-465e-9db3-f207177151e62026-05-28WarningsExact identifier
unii: 3K9958V90M
Antiseptic Hand SanitizerALCOHOLHubei Fanjian Medical Product Co.,Ltd9b4014a3-6296-4628-9cc6-b8d4ef4a25f32026-05-28WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Midnight Freesia ScentedALCOHOLFourstar Group USA, Inc.e145d190-5290-47d9-9961-e35f746e6b5a2026-05-28WarningsExact identifier
unii: 3K9958V90M
Alcohol Cleansing WipeALCOHOLHubei Fanjian Medical Product Co.,Ltdf278a911-ac4e-6868-e053-2a95a90a2ee32026-05-28WarningsExact identifier
unii: 3K9958V90M
Insect Sting ReliefBENZOCAINE, ALCOHOLHubei Fanjian Medical Product Co.,Ltdf30401c1-961e-44dd-e053-2a95a90a69d62026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Warm DriftwoodALCOHOLMy Imports Usa, LLCb8457e01-e95f-4507-ac83-3c537c4677392026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer White MuskALCOHOLMy Imports Usa, LLCee41e0d2-7109-4423-82db-2c751de6a5d82026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Caramel CinnamonALCOHOLMy Imports Usa, LLCa77a074b-662a-4d40-a73e-6fe215d2c22f2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Bergamot WaterALCOHOLMy Imports Usa, LLC4e709d1b-b902-4c40-b156-70b3e0f31cc22026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Tropical MelonALCOHOLMy Imports Usa, LLCb12baf08-4a3d-4e5a-9720-a9d2174a01242026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Champagne AppleALCOHOLMy Imports Usa, LLC84b2359f-3446-4b2a-abc5-6503209bc06f2026-05-28WarningsExact identifier
unii: 3K9958V90M
Ashley Belle Moisturizing Hand Sanitizer Sunset AmberALCOHOLMy Imports Usa, LLC004452a0-7e99-4487-8311-6e428e3c0f262026-05-28WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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