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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61958-1202-7	2025-01-30	C162847	48780-1	ab0e2407-2cd3-f274-e053-dbdaa90a6471	These 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
61958-1202-4	2020-07-22	C162847	48780-1	ab0e2407-2cd3-f274-e053-dbdaa90a6471	These 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
61958-1202-6	2020-07-22	C162847	48780-1	ab0e2407-2cd3-f274-e053-dbdaa90a6471	These 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
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-1202	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	9	Unmatched	20210417_d52f7766-068f-4a2f-b748-356ff60450f7.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
cobicistat	ACTIVE INGREDIENT	LW2E03M5PG	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
elvitegravir	ACTIVE INGREDIENT	4GDQ854U53	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
emtricitabine	ACTIVE INGREDIENT	G70B4ETF4S	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
tenofovir disoproxil fumarate	ACTIVE INGREDIENT	OTT9J7900I	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
cobicistat	ACTIVE MOIETY	LW2E03M5PG	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
elvitegravir	ACTIVE MOIETY	4GDQ854U53	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
emtricitabine	ACTIVE MOIETY	G70B4ETF4S	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
TENOFOVIR ANHYDROUS	ACTIVE MOIETY	W4HFE001U5	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	STRIBILD ACCESS (ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE) TABLET, FILM COATED [GILEAD SCIENCES, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STRIBILD 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 84 of 141 · 2,813 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dust-Mold-Dander	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.	Newton Laboratories, Inc.	9bb84bae-9019-ed76-e053-2a95a90a5c3e	2025-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Dust-Mold-Dander	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ANTIMONIUM CRUDUM, APIS MELLIFICA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BLATTA ORIENTALIS, BROMIUM, BRYONIA, CANDIDA ALBICANS, CARDUUS BENEDICTUS, CAT HAIR, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, DOG HAIR, HISTAMINUM HYDROCHLORICUM, HOUSE DUST, IPECACUANHA, LYCOPODIUM CLAVATUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHUS TOXICODENDRON, SECALE CORNUTUM, SILICEA, USTILAGO MAIDIS, TORULA CEREVISIAE.	Newton Laboratories, Inc.	9ba993f4-97af-4119-e053-2995a90a126d	2025-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
Ear Wax Build-Up	ELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATA	Newton Laboratories, Inc.	9302b838-6003-ba6a-e053-2995a90aedd3	2025-02-06	Warnings	Exact identifier unii: ETJ7Z6XBU4
DR.JART CICAPAIR TIGER GRASS COLOR CORRECTING TREATMENT	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cfe6a6-c2e4-8fb8-e063-6294a90adc78	2025-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Medium-Tan	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a8bab8-ca5d-6b65-e063-6294a90abb07	2025-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Fair-Light	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a82029-bdb1-cbe0-e063-6294a90a08f3	2025-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Premium Beauty Balm Light Medium-Medium	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Have & Be Co., Ltd.	02a87c6b-3c7d-5942-e063-6294a90aa452	2025-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
DR.JART EVERY SUN DAY MINERAL SUN SCREEN	TITANIUM DIOXIDE, ZINC OXIDE	Have & Be Co., Ltd.	02a671ed-485d-d6b7-e063-6394a90ad4af	2025-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
Dr.Jart Cicapair Tiger Grass Camo Drops	ZINC OXIDE, TITANIUM DIOXIDE	Have & Be Co., Ltd.	01cf0522-a3c1-aea8-e063-6294a90aabfe	2025-02-06	Warnings	Exact identifier unii: 15FIX9V2JP
PRID	ICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFUR	Hyland's Inc.	d22eca2f-d7e6-3412-e053-2995a90a6384	2025-02-05	Warnings	Exact identifier unii: ETJ7Z6XBU4
Jacksons Cell Salts 12 IN 1	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA	Zettl Health Inc.	25ba49d0-0369-3666-e063-6294a90a71c4	2025-02-04		Exact identifier unii: ETJ7Z6XBU4
Jacksons Cell Salts SILICA 6X 12	SILICEA	Zettl Health Inc.	2d5d1bf7-3754-1f60-e063-6294a90aee06	2025-02-04		Exact identifier unii: ETJ7Z6XBU4
Stribild	ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE	Gilead Sciences, Inc.	74ae2a93-b267-444c-8f0f-a2a6522260ee	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: LW2E03M5PG unii: OTT9J7900I unii: 4GDQ854U53 unii: G70B4ETF4S
Brush On Block Sun Shine SPF 30 Protective Lip Oil Peony Tint	TITANIUM DIOXIDE/ZINC OXIDE	SPF Ventures LLC	2d490531-af36-87d0-e063-6394a90acf49	2025-02-03	Warnings	Exact identifier unii: 15FIX9V2JP
Genvoya	ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE	Gilead Sciences, Inc.	34784acf-15ed-4715-b504-eb30430518e9	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: LW2E03M5PG unii: 4GDQ854U53 unii: G70B4ETF4S
PAULAS CHOICE HYDRALIGHT SHINE-FREE DAILY MINERAL COMPLEX Broad Spectrum SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Paula's Choice, Inc	b90658d0-e422-4265-a6ee-39c29b6c116a	2025-01-31	Warnings	Exact identifier unii: 15FIX9V2JP
SunStation USA SPF-30 SPORT SUNSCREEN	ZINC OXIDE	RENU LABORATORIES, LLC	11d3c60e-238d-999e-e063-6394a90a624b	2025-01-31	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE AND ZINC OXIDE	DERM ASSO. MID OHIO	2d04bc5d-6f11-4f56-e063-6294a90ae755	2025-01-31	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	2d0766a1-4091-e84a-e063-6394a90a004a	2025-01-31	Warnings	Exact identifier unii: 15FIX9V2JP
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIR	OCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDE	Bluemercury	5c590aed-d2f2-4478-8919-37c848752b42	2025-01-29	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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