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 37 of 142 · 2,835 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	468d6476-127a-e9f0-e063-6294a90a3df9	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3e65ec1a-0ed9-433d-8da9-a6cb61829911	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
StellaLife VEGA Oral Care Peppermint Pain and Swelling Relief	ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIA	StellaLife, Inc.	10d42c12-713a-f461-e063-6294a90a223b	2025-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Pain and Swelling Relief	ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA	StellaLife, Inc.	10f8dee1-d5d3-0602-e063-6294a90a6dbf	2025-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
THE MELT MIST Sheerest Mineral Mist Suncare for Body	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	465d3277-7798-512a-e063-6294a90a2065	2025-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7287078e-67ff-41fe-bc8d-59b2146f5dc9	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b6095639-e2ee-418e-b4f1-e59da1bd9216	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8c6466a6-4f11-4210-bb02-eb31c15984cd	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	07f8282b-047b-4be1-8779-39ed5dd6fb5d	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5a8c67c1-aeba-490d-8347-a30916efcf3b	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	739450b0-8cd7-41de-8cd0-1827e02478c6	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	08b0e056-583a-474b-aaaa-ecea05703044	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a89af40e-cf45-4afc-aac7-5f71a05bcd3f	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6da72e20-f2d7-492e-9b65-b5ac73bc0029	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	de615c3e-669f-493c-9c75-73dfbe726c59	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	152790ba-aeda-4c2a-b725-7e040e832883	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c87e5201-f7fd-4fd9-adeb-d6af9be00db6	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84cdaad2-5b7d-4841-bef6-ffad4fe6907a	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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