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 78 of 282 · 5,629 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cc0f19fc-7b6f-4454-9a77-dc11f0fd1251	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c361a514-5fc9-42a7-b1fc-28e4a11ad733	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	db38ced5-dfbe-4b7e-b4ae-3065df1898b0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ead1ce8-f31d-4676-8619-8d49dd62db2e	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	827caf09-222e-487a-941c-44eb5c13d5d6	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f3c378e1-853b-463e-9fc3-6a54ef861044	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3a479c4-807e-4c52-a27f-eea8705b9c1e	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cb63faaa-82d8-469a-a9a1-88b09e02cc35	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c20b0b8b-366a-47ff-84b6-264fa8ed6de0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31d89246-418d-4ed4-8e32-7aa2422073a9	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31b74e11-c5e5-4086-baa5-e7a39dc556a0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	29ec217b-7726-4590-8a0d-e4b08217e222	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ceabea37-020c-49e0-a049-3100ed46ff57	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	915a0b1f-b26e-4fea-95f3-ccec2bcab389	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	9a313d8e-003d-4d40-b892-0f2270e4f6c2	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f560de93-4099-4ad9-8eb6-fe2a52ac82a1	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	824c5f13-970e-4e9e-8f2a-2a01973d2e59	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b7621ef5-47fc-4ccc-aedd-eac328ace7b9	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 3C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	64a29ff8-e24d-4818-9b54-734a0eb2a13f	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2WP Warm Peach	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	17a0201b-b797-4e65-838f-1ce8d408a020	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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