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 9 of 145 · 2,883 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BM Tooth Remineralization	CALC PHOS, CALC FLUOR, SILICEA	BM Private Limited	5331dc40-2ac8-5fce-e063-6394a90a5875	2026-06-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
KIEHLS DERMATOLOGIST SOLUTIONS BETTER SCREEN MINER ALL UV SERUM BROAD SPECTRUM SPF 50 PLUS MINERAL SUNSCREEN	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc	294e6049-12b5-4b45-ae00-8ee1d9d2a1a4	2026-05-29	Warnings	Exact identifier unii: 15FIX9V2JP
O HUI DAY SHIELD PERFECT SUN BLACK BROAD SPECTRUM SPF 50 SUNSCREEN	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	LG H&H Co., Ltd.	52ba9423-8b9b-38f7-e063-6394a90a95da	2026-05-26	Warnings	Exact identifier unii: 15FIX9V2JP
Bacteriostatic Water	BACTERIOSTATIC WATER	Hospira, Inc.	87d6e9dc-fe3b-4593-ac9a-d7493d1959c7	2026-05-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Mineral SPF 30 Moisturizer	MINERAL SPF 30 MOISTURIZER	Dont Run Out Inc (DBA: Public Goods)	52462e7e-0c2c-6b64-e063-6394a90a4230	2026-05-21	Warnings	Exact identifier unii: 15FIX9V2JP
DRMTLGY Radiance Powder	TITANIUM DIOXIDE, ZINC OXIDE	DRMTLGY	15bda8d5-8c3c-6ba5-e063-6394a90a82d9	2026-05-21	Warnings	Exact identifier unii: 15FIX9V2JP
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Major Pharmaceuticals	a78b51c9-c944-4b00-af81-9ecbfbb29fd1	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S
SkinCeuticals Future Mineral UV Defense Invisble Sunscreen Mineral Filters Broad Spectrum SPF 50	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	0b92a940-0dd4-4266-bd47-88c27def62c0	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
WHITENING SUNSCREENANTI WRINKLE	WHITENING SUNSCREENANTI WRINKLE	Shantou Oushiya Biotechnology Co.,Ltd	524384e9-b3f8-4c13-e063-6394a90a8973	2026-05-20	Warnings	Exact identifier unii: 059QF0KO0R unii: 15FIX9V2JP
IT COSMETICS HELLO SUNSHINE Invisible Sunscreen Broad Spectrum SPF 50 UVA UVB Mineral 50	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc.	fded7dfb-ffb9-4fb0-9511-273e0e126969	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Freaks of Nature Peak Performance Broad Spectrum SPF 50	FREAKS OF NATURE PEAK PERFORMANCE BROAD SPECTRUM SPF 50	THE FREAKS OF NATURE, INC.	5247187d-a14c-6468-e063-6394a90ace3e	2026-05-20	Warnings	Exact identifier unii: 15FIX9V2JP
Dentaforce	ANTIMONIUM CRUDUM, BELLADONNA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, MERCURIUS SOLUBILIS, PLUMBUM METALLICUM, SEPIA, SILICEA, HYDROFLUORICUM ACIDUM	BioActive Nutritional, Inc.	82321547-e04a-42ff-aa39-6a192638e5a2	2026-05-18	Warnings	Exact identifier unii: ETJ7Z6XBU4
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	LOreal USA Products Inc.	23cc5ff4-f842-4e3e-ac5c-23dbaf7d3914	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
LANCOME PARIS UV EXPERT SUPRA SCREEN MINERAL INVISIBLE SUNSCREEN SPF 50 SERUM	TITANIUM DIOXIDE AND ZINC OXIDE	SICOS ET CIE	c688f8e6-2cd2-40db-b03f-90fd74c2d89c	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	7df9dbd2-7db9-4961-819d-e93d14a065c3	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
Lancome Paris Teint Idole Ultra Wear Breathable Coverage Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	SICOS ET CIE	20efd5fa-3077-4fd4-82d0-ddca946e4528	2026-05-15	Warnings	Exact identifier unii: 15FIX9V2JP
MELAO Hydrating Lightweight Sunscreen	OCTOCRYLENE,HOMOSALATE,ETHYLHEXYL SALICYLATE,PHENYLBENZIMIDAZOLE SULFONIC ACID,BUTYL METHOXYDIBENZOYLMETHANE,TITANIUM DIOXIDE	Guangdong Aimu Biological Technology Co., Ltd	51c353cb-94c4-e110-e063-6394a90a497e	2026-05-14	Warnings	Exact identifier unii: 15FIX9V2JP
C07 STRONG LIGAMENTS AND JOINTS	ARNICA MONTANA, ASCORBICUM ACIDUM, BOS TAURUS LYMPH VESSEL, INTERVERTEBRAL FIBROCARTILAGE, BOS TAURUS MESENCHYME, CALCAREA PHOSPHORICA, CARTILAGO SUIS, FORMICUM ACIDUM, LAPIS ALBUS, PINUS MONTANA LEAFY TWIG, RHAMNUS CALIFORNICA, RHUS TOXICODENDRON, RUTA GRAVEOLENS, SILICEA, SUS SCROFA JOINT ENVELOPE, SUS SCROFA LIGAMENT, SUS SCROFA MENISCUS, SUS SCROFA PARATHYROID GLAND, SUS SCROFA VEIN, SYMPHYTUM OFFICINALE	Apex Energetics Inc.	bccf8c83-a6cd-e58c-e053-2a95a90a43d7	2026-05-13	Warnings	Exact identifier unii: ETJ7Z6XBU4
Even Tone Mineral Sunscreen Broad Spectrum SPF 36 Medium - Dark	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	aedde765-931f-430e-9fc3-d87bde2b78cd	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP
Even Tone Mineral Sunscreen Broad Spectrum SPF 40 Light - Medium	TITANIUM DIOXIDE AND ZINC OXIDE	SENT, Inc.	417305d7-d32e-4bc9-8f77-0a42b6bdecf5	2026-05-12	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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