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#

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 49 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Surface Hand Sanitizer SurpriseETHYL ALCOHOLLongway Technology(Guangzhou)Co.,Ltd.4ec389af-d85a-98f5-e063-6394a90a99512026-04-05WarningsExact identifier
unii: 3K9958V90M
Caring Mill Triple Hand Sanitizer with LavenderETHYL ALCOHOLFSA Store Inc. (Caring Mills)4b0b5436-a1ce-cfa6-e063-6394a90a2efe2026-04-04WarningsExact identifier
unii: 3K9958V90M
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
EltaMD Skincare UV AOX Elements SPF50 TintedTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc2c74209d-9b88-4c32-ad42-cd6de16c1fef2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Restore TintedTITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENCP Skin Health Group, Inc4fc18856-01b3-43ed-9e1b-b4394e31aa3c2026-04-03WarningsExact identifier
unii: 15FIX9V2JP
Sunscreen for baby SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co., Ltd.1cb7fbca-0874-ae53-e063-6294a90ab42a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
TiZO3TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD4e7bdec2-abcc-0267-e063-6394a90ae47a2026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Hand Sanitizer Passion ParadiseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e850ea9-0999-12b4-e063-6394a90af4062026-04-02WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Tropical MangoALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85630a-6d18-e6a4-e063-6394a90a1d122026-04-02WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Coco CabanaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85923b-6b8c-f9a2-e063-6294a90a0d8e2026-04-02WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Sea BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85e279-7751-8bd7-e063-6294a90a095b2026-04-02WarningsExact identifier
unii: 3K9958V90M
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc17b47994-82d6-4f9d-8249-bdb55106c9b32026-04-02WarningsExact identifier
unii: 15FIX9V2JP
Sinus DefenseLAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC9c2f51c5-aa41-414e-a966-32e02e9e79a22026-04-02WarningsExact identifier
unii: ETJ7Z6XBU4
Clinical Skin Filter Tinted SunscreenCLINICAL SKIN FILTER TINTED SUNSCREENBY KIN AESTHETICS LLC4e69a8a3-8dbb-577a-e063-6294a90a6a232026-04-01WarningsExact identifier
unii: 15FIX9V2JP
Krx Aesthetics All Day Glow SunblockerKRX AESTHETICS ALL DAY GLOW SUNBLOCKERBY KIN AESTHETICS LLC4e69df43-393b-bc09-e063-6394a90a275a2026-04-01WarningsExact identifier
unii: 15FIX9V2JP
FRESH LINES SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5005d615-d9c3-a46d-e063-6394a90af88a2026-04-01WarningsExact identifier
unii: 3K9958V90M
PINK SUGAR SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5005eac6-4032-23e0-e063-6294a90a81b52026-04-01WarningsExact identifier
unii: 3K9958V90M
VANILLA DREAM SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd50060be0-ec68-c82b-e063-6394a90aa7232026-04-01WarningsExact identifier
unii: 3K9958V90M
STRAWBERRY FIZZ SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd500621d8-bc77-218d-e063-6394a90ad05f2026-04-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY COCONUT VANILLA HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e5-d180-e063-6394a90ae0c22026-04-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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