FDA.reportPublic FDA data

NDC 61958-1805-01 - Harvoni

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
61958-1805
Requested NDC
61958-1805-01
Package NDCs from labels
61958-1805-1, 61958-1805-01
Manufacturer
Gilead Sciences, Inc
Effective date
2024-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Harvoni - Gilead Sciences, IncGilead Sciences, Inc2024-12-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1805-1Harvoni90 in 1 PACKETPELLET9017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1805HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC]17Current NDC, Legacy NDC, 1 package rows20250112_f4ec77e4-bae8-4db0-b3d5-bde09c5fa075.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61958-1805-1EA - Each61958-18054f6681e0-f3a1-4afd-9727-e83a825837c512020-06-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LEDIPASVIRACTIVE INGREDIENT013TE6E4WVHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
SOFOSBUVIRACTIVE INGREDIENTWJ6CA3ZU8BHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
LEDIPASVIRACTIVE MOIETY013TE6E4WVHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
SOFOSBUVIRACTIVE MOIETYWJ6CA3ZU8BHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
ALCOHOLINACTIVE INGREDIENT3K9958V90MHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8BHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4
WATERINACTIVE INGREDIENT059QF0KO0RHARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]4

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 1 of 292 · 5,833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Advanced Alcohol Gel SanitizerALCOHOLBetco Corporation, Ltda23b997c-b010-5985-e053-2995a90aadf32026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cotton CandyALCOHOLChurch & Dwight Co., Inc.5b107dd2-a76c-9c80-e063-6394a90aaedb2026-09-09WarningsExact identifier
unii: 3K9958V90M
Pink Touchland Power Mist Hydrating Hand Sanitizer Wild WatermelonALCOHOLChurch & Dwight Co., Inc.5b108f13-6474-fdbd-e063-6294a90a1a2b2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mango PassionALCOHOLChurch & Dwight Co., Inc.5b1099ae-f1e8-b79d-e063-6394a90add6f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Gentle Mist Hand Sanitizer Lily of The ValleyALCOHOLChurch & Dwight Co., Inc.5b10a3a7-1cca-2a34-e063-6294a90a3f6c2026-09-09WarningsExact identifier
unii: 3K9958V90M
Touchland Glow Mist Hand Sanitizer RosewaterALCOHOLChurch & Dwight Co., Inc.5a850866-bc5d-e595-e063-6394a90a335f2026-09-09WarningsExact identifier
unii: 3K9958V90M
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: 532B59J990
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
hand sanitizer - cherry sundaeALCOHOLGanzhou Olivee Cosmetic Co., Ltd.270d2ce0-6310-4a84-be8a-72db6062bae72026-09-07WarningsExact identifier
unii: 3K9958V90M
hand sanitizer - vanilla frostingALCOHOLGanzhou Olivee Cosmetic Co., Ltd.f6cabda2-6e1c-4238-9a2e-df10e263517d2026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - beaver nuggetsALCOHOLGanzhou Olivee Cosmetic Co., Ltd.ba3612b3-9696-417a-ba66-eb9dc5ea27c62026-09-07WarningsExact identifier
unii: 3K9958V90M
hydrating mist hand sanitizer with silicone keychain holder - signature scentALCOHOLGanzhou Olivee Cosmetic Co., Ltd.5b0ac694-66e0-437f-86cd-09f259344b892026-09-07WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Crush On You - Peach SkinALCOHOLScent Theory Products LLC5ac32582-d888-edf4-e063-6394a90a40ab2026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Be Mine - Sugared BerriesALCOHOLScent Theory Products LLC5ac32ffb-926a-f249-e063-6394a90a8d872026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - UR Sweet - Sweet Cherry Hand SanitizerALCOHOLScent Theory Products LLC5ac33b21-9192-8baa-e063-6294a90a6e752026-09-05WarningsExact identifier
unii: 3K9958V90M
Sweethearts - Ooo La La - Banana Cream Hand SanitizerALCOHOLScent Theory Products LLC5ac34dda-fbdf-0ca7-e063-6394a90ab7642026-09-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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