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 75 of 282 · 5,629 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOP Ethyl Alcohol 70%	ETHYL ALCOHOL	Omega & Delta Co., Inc.	b96d85f8-739c-4b96-9dd5-8119ebf66c9f	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Rose Lychee	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	48dfcbe1-8e0c-1715-e063-6394a90a733f	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 13C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	be9f7608-cfaa-4b16-83dd-0580047af56c	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6b27df44-c441-4ae8-a1b0-a9cf2fff6f21	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	3c295f6b-6202-a2e1-e063-6394a90a9a60	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	b2eee48f-b644-403c-a57e-04a1491bc386	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	ebcc2c6c-a039-48d5-8c1c-5b347254c4c2	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	6967f8bc-3092-44a9-926a-6c11676425e5	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	37d4d8c1-e76b-48a3-9a13-f0543af1b28f	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24W	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	fa5046f2-a6db-4ac3-a78f-1b5df075d7e8	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25N	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	0c5fc63f-1899-4406-944a-1cdcdf8b4277	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27C	OCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDE	Aekyung Industrial Co., Ltd.	58a84ecd-3f27-40fc-8e0b-e29192679e6b	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
BioMicroneedle PDRN Cream	SILICON DIOXIDE	Guangzhou Shengyanghui Industrial Trading Co., Ltd	48e2edae-94ea-c42e-e063-6394a90a907b	2026-01-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
LIGHTS Insect Sting Relief Pad	BENZOCAINE	Lights Medical Manufacture Co., Ltd.	ccb4185c-1a67-4775-9392-16bc0f7df3cc	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Blueberry Freesia	ETHYL ALCOHOL	MY IMPORTS USA LLC	48f0a73a-66b5-e7d0-e063-6394a90a2333	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Lemon Sugar Blossom	ETHYL ALCOHOL	MY IMPORTS USA LLC	48f127be-8259-5aaa-e063-6294a90a3f1a	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
sunscreen	TITANIUM DIOXIDE	Guangdong Zhoubang Biotechnology Co., Ltd	48f13b1c-8104-881b-e063-6394a90a816d	2026-01-21	Warnings	Exact identifier unii: 15FIX9V2JP
AshleyBelle Moisturizing Hand Sanitizer Rose Lychee	ETHYL ALCOHOL	MY IMPORTS USA LLC	48f2433f-b924-ade1-e063-6394a90a2c9a	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
AshleyBelle Moisturizing Hand Sanitizer Pineapple Soleil	ETHYL ALCOHOL	MY IMPORTS USA LLC	48f2527c-a83e-f709-e063-6394a90aa030	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M
Walgreens SWEET PEA PETALS Hand Sanitizer Mist	ETHYL ALCOHOL	Walgreen Co.	9867c899-980b-4272-8716-41e7c27cdcb8	2026-01-21	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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