FDA.reportPublic FDA data

NDC 61958-1502 - Sovaldi 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
61958-1502
Package NDCs from labels
61958-1502-2
Manufacturer
Gilead Sciences, Inc.
Effective date
2020-12-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sovaldi Access - Gilead Sciences, Inc.Gilead Sciences, Inc.2020-12-20HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-1502-22025-01-30C16284748780-12cef2736-67bf-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI. GILEAD ACCESS PROGRAM SOVALDI™ (sofosbuvir) tablets, for oral use Initial U.S. Approval: 2013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61958-1502-2Sovaldi Access28 in 1 BOTTLETABLET, FILM COATED289

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1502SOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]91 package rows20201222_b66d2de5-8550-4015-9c2c-d7a9150926b4.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SOFOSBUVIRACTIVE INGREDIENTWJ6CA3ZU8BSOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
SOFOSBUVIRACTIVE MOIETYWJ6CA3ZU8BSOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
MANNITOLINACTIVE INGREDIENT3OWL53L36ASOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1USOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSOVALDI ACCESS (SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2

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 61 of 139 · 2,764 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral Mist SPF-50TITANIUM DIOXIDE, ZINC OXIDETUBBY TODDdca54a19-af25-ce47-e053-2a95a90a22db2025-12-07WarningsExact identifier
unii: 15FIX9V2JP
Solbar Shield SPF40SOLBAR SHIELD SPF40Person and Coveybd3a9a94-fc87-4127-abf9-29e56ac9ce5d2025-12-04WarningsExact identifier
unii: 15FIX9V2JP
BM BIO28 ICING SUGARCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEABM Private Limited3e855f3b-c73d-a153-e063-6394a90ad63a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products Bio28CALC 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 Micro3e85a931-57f6-2a55-e063-6294a90ac1802025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Bestmade Natural Products BIO28CALC 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 Micro3e46ee90-2c2c-0a70-e063-6294a90a576a2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM SiliceaSILICEABM Private Limited37b0535d-6bcf-2d40-e063-6294a90a2a8e2025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
BM Silicea Icing SugarSILICEA ICING SUGARBM Private Limited37c1f61d-dfe4-9dcf-e063-6394a90aceb12025-12-02WarningsExact identifier
unii: ETJ7Z6XBU4
Biossance Squalane and Daily Mineral Sunscreen Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDETHG Beauty USA LLC44952d01-7f38-0a9c-e063-6394a90a20182025-11-27WarningsExact identifier
unii: 15FIX9V2JP
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD44768dd1-b132-c33b-e063-6294a90accd42025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
salmon colored sunscreenSALMON COLORED SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd4477964b-28f3-a371-e063-6294a90a42302025-11-25WarningsExact identifier
unii: 15FIX9V2JP
Gout Pain ManagementARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFForces of Nature9276fe9c-d9a2-4cef-986c-5d7d39f2d6a12025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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