NDC 61958-1802 - Harvoni 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: 61958-1802
Package NDCs from labels: 61958-1802-6
Manufacturer: Gilead Sciences, Inc
Effective date: 2025-06-16
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Harvoni Access - Gilead Sciences, Inc	Gilead Sciences, Inc	2025-06-16	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61958-1802-6	2025-06-20	C162847	48780-1	2cef2736-72b0-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014
61958-1802-6	2025-01-30	C162847	48780-1	2cef2736-72b0-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use HARVONI™ safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-1802-6	Harvoni Access	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-1802	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	9	1 package rows	20210701_1a1c555d-2fdf-4150-8ace-dbc770c226bf.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEDIPASVIR	ACTIVE INGREDIENT	013TE6E4WV	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
SOFOSBUVIR	ACTIVE INGREDIENT	WJ6CA3ZU8B	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
LEDIPASVIR	ACTIVE MOIETY	013TE6E4WV	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
SOFOSBUVIR	ACTIVE MOIETY	WJ6CA3ZU8B	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HARVONI ACCESS (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	1

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 96 of 281 · 5,610 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Fair	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	473738b4-7c36-8edf-e063-6394a90ad24b	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47387d5f-e77b-5633-e063-6294a90a5584	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738be66-0fe8-148e-e063-6394a90a1b02	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4738eed1-9f72-5fd8-e063-6394a90a26bd	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Deep	HOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4739179e-88b3-8820-e063-6394a90aa211	2025-12-30	Warnings	Exact identifier unii: 15FIX9V2JP
Good Sense Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Geiss, Destin & Dunn, Inc.	9b243301-2e4b-5706-e053-2995a90a9b90	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Family Wellness Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Family Dollar Services, Inc.	facd329b-1923-61df-e053-6294a90ab738	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	KC Pharmaceuticals, Inc.	eb6eb6c4-1609-407b-84e4-c7509811f3c0	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Publix Artificial Tears Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Publix Super Markets, Inc.	f5d1394b-0fe8-c372-e053-2a95a90a1f78	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Best Choice Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Best Choice	f5ba63f3-7966-81fe-e053-2995a90a342c	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Kroger Eye Drops Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	The Kroger Company	f76f08c5-0111-8bc5-e053-6294a90a16ee	2025-12-30	Warnings	Exact identifier unii: 532B59J990
CareOne Artificial Tears Eye Drops 15mL	POLYVINYL ALCOHOL, POVIDONE	Retail Business Services, LLC	92fded6b-91fd-d82e-e053-2a95a90ab523	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Quality Choice Artificial Tears Lubricant Eye Drops	POLYVINYL ALCOHOL, POVIDONE	Chain Drug Marketing Association, Inc.	1f669655-4bc7-0175-e063-6294a90a305a	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Equate Artificial Tears	POLYVINYL ALCOHOL, POVIDONE	Walmart, Inc.	ead9f271-0f15-1fff-e053-2a95a90a93ac	2025-12-30	Warnings	Exact identifier unii: 532B59J990
Quality Choice Eye Wash	WATER	Chain Drug Marketing Assoc., Inc.	1fb8a109-351b-7039-e063-6394a90a7311	2025-12-30	Warnings	Exact identifier unii: 059QF0KO0R
Rite Aid Eye Wash	PURIFIED WATER	Rite Aid	28a18e04-d735-a511-e063-6394a90af6bb	2025-12-30	Warnings	Exact identifier unii: 059QF0KO0R
Alcohol Gel Hand Sanitizer	ALCOHOL	Ecolab Inc.	6305da7a-f21c-4e94-a2c1-e1faac489df6	2025-12-30	Warnings	Exact identifier unii: 3K9958V90M
Protecting FHS	ALCOHOL	Ecolab	50d1e501-c143-4446-84e7-7f3f278166af	2025-12-30	Warnings	Exact identifier unii: 3K9958V90M
Facilipro Protecting FHS	ALCOHOL	Ecolab	d6fccda4-f565-406b-aeb6-585b59bddf51	2025-12-30	Warnings	Exact identifier unii: 3K9958V90M
Retail Hand Sanitizer	ALCOHOL	Ecolab Inc.	55e65545-9869-413b-8239-bd2d43fe36d8	2025-12-30	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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