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 63 of 282 · 5,629 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Everyone Hand Sanitizer Lavender Aloe	ALCOHOL	EO Products, LLC	d15c1fb9-b25b-45b8-a119-ee4c86c8d91c	2026-03-03	Warnings	Exact identifier unii: 3K9958V90M
Advanced Hand Sanitizer	ETHYL ALCOHOL	Amazon.Com Services LLC	85421e9a-f1c9-4793-9479-8a072a610ed7	2026-03-03	Warnings, Adverse reactions	Exact identifier unii: 3K9958V90M
FOOTSPA PEDI	ALCOHOL	CHEMCO CORPORATION	3886a958-d035-ed15-e063-6294a90af1b5	2026-03-03	Warnings	Exact identifier unii: 3K9958V90M
Anti Bacterial Moisturizing Hand Sanitizer Starfruit Sangria	ALCOHOL	Bath & Body Works, Inc.	387caf6b-fda0-a63f-e063-6294a90a041a	2026-03-03	Warnings	Exact identifier unii: 3K9958V90M
Alcohol	ALCOHOL	Old East Main Co.	31a38e0e-41de-4638-9e86-df1923b64d52	2026-03-02	Warnings, Adverse reactions	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Lavender and Vanilla	ALCOHOL	Bath & Body Works, Inc.	29a37aad-c6d3-b174-e063-6394a90abc3e	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Lavender and Vanilla	ALCOHOL	Bath & Body Works, Inc.	38d5a11f-d0cb-30eb-e063-6394a90a6a49	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and Vanilla	ALCOHOL	Bath & Body Works, Inc.	2b0f3ca1-0a68-08a6-e063-6294a90a9df2	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti Bacterial Hand Gel Lavender and Vanilla	ALCOHOL	Bath & Body Works, Inc.	38e1c1d6-6511-4066-e063-6294a90ad3f4	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Ethyl Alcohol	ETHYL ALCOHOL	Old East Main Co.	479d5880-1e7e-481e-98df-dd98324d6ab8	2026-03-02	Warnings, Adverse reactions	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray White T Shirt	ALCOHOL	Bath & Body Works, Inc.	29a38d22-0685-37af-e063-6294a90a31e6	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Passionfruit and Banana Flower	ALCOHOL	Bath & Body Works, Inc.	38d5d6c2-8ceb-40b7-e063-6394a90a2a8f	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray A Thousand Wishes	ALCOHOL	Bath & Body Works, Inc.	29a3aac8-2083-3ece-e063-6394a90ab440	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Ocean	ALCOHOL	Bath & Body Works, Inc.	29a38d22-068a-37af-e063-6294a90a31e6	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Champagne Toast	ALCOHOL	Bath & Body Works, Inc.	29a3aa8a-c697-a873-e063-6294a90a72c4	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Peach Bellini	ALCOHOL	Bath & Body Works, Inc.	297e26d2-128e-0aa5-e063-6294a90a34dc	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Waikiki Beach Coconut	ALCOHOL	Bath & Body Works, Inc.	38d5cfd5-db0d-4735-e063-6394a90a42a8	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Sunshine and Lemons	ALCOHOL	Bath & Body Works, Inc.	297e95be-a862-9d13-e063-6294a90a9faa	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Sweet Kiwi and Starfruit	ALCOHOL	Bath & Body Works, Inc.	38d5d1c4-7f5b-45af-e063-6394a90a9c47	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M
Anti-BacterialHandSpray Ocean	ALCOHOL	Bath & Body Works, Inc.	38d5c6ac-4e71-3e9e-e063-6394a90af6c2	2026-03-02	Warnings	Exact identifier unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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