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 20 of 285 · 5,690 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
The Cell Salt Co. Daily Blend 12 in 1	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA	The Cell Salt Company LLC	55826f59-acf4-7370-e063-6394a90afed7	2026-07-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Medi Fect Antiseptic Hand Wash	ETHYL ALCOHOL	Medical Chemical Corporation	dc397d9c-9c12-41e5-ab7f-196fcad5bf97	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
AloeSafe Antiseptic Hand Sanitizer	ETHYL ALCOHOL	Medical Chemical Corporation	950f012e-7908-523c-e053-2995a90afa6b	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Berry Bliss	ALCOHOL	Bath & Body Works, Inc.	55935d41-ce7a-796a-e063-6294a90a6ba2	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Tangerine Twirl	ALCOHOL	Bath & Body Works, Inc.	55933da8-dfbc-6877-e063-6394a90abb7f	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Watermelon Whirl	ALCOHOL	Bath & Body Works, Inc.	559364cc-2b55-9628-e063-6394a90ac8e6	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	55984504-188f-13bc-e063-6394a90a9150	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Amber Glow	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5597ed5f-ed98-ebeb-e063-6294a90a2e8d	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5598c831-3986-00a5-e063-6394a90a1e66	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Apple Splash	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	55982f73-7baa-26a7-e063-6394a90ab74b	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	55981d2a-d4de-af08-e063-6294a90a4b7c	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5597ff1f-b134-0beb-e063-6394a90a39a1	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5598d6ca-39f6-ca2a-e063-6394a90abc0e	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559832ca-df92-0c2d-e063-6294a90ab66f	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio Glow	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5599605b-28f0-a534-e063-6394a90a7213	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559987c0-7abd-13fc-e063-6294a90a9f27	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
MISTIFY STRAWBERRE HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5740a2ed-e77d-3f41-e063-6394a90aec03	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
MISTIFY VANILLA HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574ba9b9-b44d-b014-e063-6394a90af768	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
MISTIFY COTTON CANDY HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574bcf4f-ad36-5ede-e063-6294a90a0eab	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M
MISTIFY COCONUT HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	57539bdd-641d-3c27-e063-6394a90af84a	2026-07-01	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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