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 73 of 141 · 2,813 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dolce and Gabbana Everlast Foundation SPF 20 33N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e249507c-d536-4c1d-a99d-857ca1e833d8	2025-08-29	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	ba99edea-bf68-4118-8bb7-ea40322db46a	2025-08-29	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 34W Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	3a239897-9850-417f-8c00-e810a52540c1	2025-08-29	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 36N Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	c495afc3-6486-4652-b743-958f28eccaca	2025-08-29	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 35W Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	5440ed13-b07e-4c81-a407-d9ac68eaa483	2025-08-29	Warnings	Exact identifier unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 37W Deep	OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	9b2c4567-fde7-4b76-9988-b2cba2d3747e	2025-08-29	Warnings	Exact identifier unii: 15FIX9V2JP
Sterile Water	WATER INJECTION	Henry Schein, Inc.	3501952b-b556-4d5e-b81b-5c35ff87b475	2025-08-28	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3d55291c-9d4c-85c3-e063-6394a90af330	2025-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3	ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Hangzhou Jingshen Trading Co., Ltd.	3d565612-ade5-bfb3-e063-6294a90a0c65	2025-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
Sun Bum 30 Mineral Tinted Sunscreen Face	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3a290aad-7f40-cb10-e063-6394a90a2e69	2025-08-27	Warnings	Exact identifier unii: 15FIX9V2JP
Allergy and Sinus Relief	PELARGONIUM SIDOIDES ROOT, HYDRASTIS CANADENSIS WHOLE, POTASSIUM CHLORIDE, SANGUINARIA CANADENSIS ROOT, PULSATILLA VULGARIS, SILICON DIOXIDE	Schwabe North American, Inc.	c90cc6f5-14ec-41a3-a20a-4e8018bb02fb	2025-08-25	Warnings	Exact identifier unii: ETJ7Z6XBU4
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 6	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3d0359b6-088f-aa54-e063-6394a90a422f	2025-08-23	Warnings	Exact identifier unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3cdc1ae9-2924-5057-e063-6294a90ad2f3	2025-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3b21f1d8-534d-f4ea-e063-6294a90ad2eb	2025-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 5	ENSULIZOLE,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3ceb3368-439c-9f6c-e063-6294a90a98ba	2025-08-21	Warnings	Exact identifier unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 2	ENSULIZOLE ,HOMOSALATE ,OCTINOXATE,TITANIUM DIOXIDE	Longway Technology(Guangzhou) Co., Ltd.	3cc8b151-c07d-7473-e063-6294a90a1cc7	2025-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
SEYE	ZINC OXIDE AND TITANIUM DIOXIDE CREAM	Guangzhou Seye Biomedical Technology Co., Ltd.	3cce91b1-311b-4c95-e063-6294a90a2d7a	2025-08-20	Warnings	Exact identifier unii: 15FIX9V2JP
Emtricitabine and Tenofovir Disoproxil Fumarate	EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE	Laurus Labs Limited	4a7ccbbf-da20-4012-9717-31c411efb3fb	2025-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: OTT9J7900I unii: G70B4ETF4S
Aurum Hypericum	AURUM HYPERICUM	Uriel Pharmacy Inc.	0c3ed6fe-8dce-0496-e063-6394a90add56	2025-08-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Fungus Fighter	CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.	Newton Laboratories, Inc.	93e05175-001b-c639-e053-2a95a90a289c	2025-08-19	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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