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 28 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Holiday- GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.547e76d4-e7ea-5cac-e063-6394a90a72942026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Sugar CookieALCOHOLShenzhen Lantern Scicence Co.,Ltd.547eaf43-ec33-b61a-e063-6294a90af6d92026-06-17WarningsExact identifier
unii: 3K9958V90M
Smart Care Holiday Hand Sanitizer-Candy CaneALCOHOLShenzhen Lantern Scicence Co.,Ltd.547ef4f4-6f0b-23ea-e063-6294a90a75332026-06-17WarningsExact identifier
unii: 3K9958V90M
HumalogINSULIN LISPROEli Lilly and Companyc8ecbd7a-0e22-4fc7-a503-faa58c1b6f3f2026-06-16Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Novo WipeNOVO WIPESHENZHEN BENLIJU BIO-TECH CO.,LTD545c6386-139e-cb9b-e063-6394a90a04562026-06-16WarningsExact identifier
unii: 3K9958V90M
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
SFL SUNSCREEN - SOL DEFENSE SPF 30TITANIUM DIOXIDE, ZINC OXIDELifeline Medical, Inc5438c185-31c9-c51e-e063-6394a90ae9ef2026-06-14WarningsExact identifier
unii: 15FIX9V2JP
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro543bc298-ec32-38e9-e063-6394a90aac152026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nail Fungus Control Extra StrengthCALENDULA OFFICINALIS FLOWERING TOP, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Natured02b88a6-1999-4dcd-91b5-fad88a664fcb2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Nerve PainARABICA COFFEE BEAN, SILICON DIOXIDE, AND HYPERICUM PERFORATUMForces of Naturea9c3ba2e-9254-4ccd-9fe9-7a360fdf2bb72026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Scar ControlCALENDULA OFFICINALIS FLOWERING TOP, ALLYLTHIOUREA, AND SILICON DIOXIDEForces of Nature595c3423-6b52-48fc-8a95-00b53c1ecc7b2026-06-14WarningsExact identifier
unii: ETJ7Z6XBU4
Sprayhand sanitizerSPRAY HAND SANITIZERJinhua Xiangyi Industrial Co., LTD5419e445-84f2-5e0e-e063-6294a90a9c752026-06-14WarningsExact identifier
unii: 3K9958V90M
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICATotal Operations Management LLC DBA:Bestmade Natural Products Micro54243745-bd67-19c1-e063-6394a90a4b722026-06-13WarningsExact identifier
unii: ETJ7Z6XBU4
BM BM186 DROPSARNICA, FERR PHOS, HYPERICUM, IGNATIA, SILICABM Private Limited540d8fbe-3bdb-1b54-e063-6394a90a114d2026-06-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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