FDA.reportPublic FDA data

NDC 61958-1202 - Stribild 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
61958-1202
Package NDCs from labels
61958-1202-7
Manufacturer
Gilead Sciences, Inc.
Effective date
2021-03-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Stribild Access - Gilead Sciences, Inc.Gilead Sciences, Inc.2021-03-29HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61958-1202-72025-01-30C16284748780-1ab0e2407-2cd3-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2012
61958-1202-42020-07-22C16284748780-1ab0e2407-2cd3-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2012
61958-1202-62020-07-22C16284748780-1ab0e2407-2cd3-f274-e053-dbdaa90a6471These highlights do not include all the information needed to use STRIBILD safely and effectively. See full prescribing information for STRIBILD. STRIBILD™ (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61958-1202STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]9Unmatched20210417_d52f7766-068f-4a2f-b748-356ff60450f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
cobicistatACTIVE INGREDIENTLW2E03M5PGSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
elvitegravirACTIVE INGREDIENT4GDQ854U53STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
emtricitabineACTIVE INGREDIENTG70B4ETF4SSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
tenofovir disoproxil fumarateACTIVE INGREDIENTOTT9J7900ISTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
cobicistatACTIVE MOIETYLW2E03M5PGSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
elvitegravirACTIVE MOIETY4GDQ854U53STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
emtricitabineACTIVE MOIETYG70B4ETF4SSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
TENOFOVIR ANHYDROUSACTIVE MOIETYW4HFE001U5STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1USTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) 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 3 of 145 · 2,883 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vac-ChordALUMINA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BOLDO, CALCAREA CARBONICA, CARDUUS MARIANUS, CHAMOMILLA, CHELIDONIUM MAJUS, ECHINACEA, HYDRASTIS CANADENSIS, LECITHIN, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MORBILLINUM, PERTUSSINUM, PHYTOLACCA DECANDRA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, TARAXACUM OFFICINALE, THUJA OCCIDENTALIS, THYROIDINUM.Energetix Corporation880ea1e6-8d4d-486e-9a8f-9d3158a996672026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Tox-ChordALFALFA, ALUMINA, BENZOICUM AC, CARBONEUM, CETRARIA, FOLLICULINUM, FUCUS, FUMARICUM AC, HEPAR SUIS, KALI CARB, KREOSOTUM, NAT MUR, PARAFFINUM, PETROLEUM, PHOSPHORICUM AC, PHOS, PIX LIQUIDA, PLANTAGO, PLUMB MET, PULSATILLA, RADIUM BROM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM, TABACUM, TEREBINTHINA, THYROIDINUM, TRITICUM, ZINC OXYD.Energetix Corporationb06b4794-e5bb-4ccd-87fd-37afca7b0f982026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Emtricitabine and tenofovir disoproxil fumarateEMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATEA-S Medication Solutions41bd03ea-b92e-459c-968b-c9095ae90aef2026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: OTT9J7900I
unii: G70B4ETF4S
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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