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 88 of 139 · 2,764 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sunscreen Emulsion SPF50plusOCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATEGuangzhou Senmai Biotechnology Co.1d560670-026b-bd34-e063-6394a90a9af42025-01-08WarningsExact identifier
unii: 15FIX9V2JP
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
sunbetter Broad Spectrum SPF 56 Sunscreen Stick SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC92c4e4cb-aadc-26f4-e053-2995a90a03d52025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Compact SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb8a4986d-c28f-c4f4-e053-2a95a90a71672025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLC8f119447-045b-43f3-e053-2995a90aea772025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 75 Sunscreen Tone SmartZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb878ee3b-6897-3c4a-e053-2995a90afed72025-01-06WarningsExact identifier
unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 70 Sunscreen SheerZINC OXIDE, TITANIUM DIOXIDESKINBETTER SCIENCE LLCb879067b-9d7f-3a62-e053-2995a90a9d6b2025-01-06WarningsExact identifier
unii: 15FIX9V2JP
glo SKIN BEAUTY Luminous Liquid Foundation SPF 18GLO SKIN BEAUTY LUMINOUS LIQUID FOUNDATION SPF 18Hayden Caleel LLCdd863361-281d-45fe-a8c1-6e4c670809a52025-01-05WarningsExact identifier
unii: 15FIX9V2JP
Dr.Jucre Rebirth BBTITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, NIACINAMIDE, ADENOSINENATURECELL CO., LTD.2ab403df-29b3-75af-e063-6394a90a6ca42025-01-02WarningsExact identifier
unii: 15FIX9V2JP
Green Defense Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEFarmacy Beauty LLCadf0f50f-6357-bc1f-e053-2a95a90ad9972025-01-02WarningsExact identifier
unii: 15FIX9V2JP
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
Exel Clarifying Line Daily Fluid Sun Shield white color Broad Spectrum SPF 60 plusOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.283c2780-5ad5-38f1-e063-6294a90ac3362025-01-01WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WHITE COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aabf782-65f9-e894-e063-6394a90a1ea32025-01-01WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEBiocosmetica Exel Argentina SRL2aad5b97-e64b-c678-e063-6294a90aa8c62025-01-01WarningsExact identifier
unii: 15FIX9V2JP
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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