NDC 61958-1801-01 - Harvoni

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: 61958-1801
Requested NDC: 61958-1801-01
Package NDCs from labels: 61958-1801-1, 61958-1801-01
Manufacturer: Gilead Sciences, Inc
Effective date: 2024-12-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Harvoni - Gilead Sciences, Inc	Gilead Sciences, Inc	2024-12-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61958-1801-1	Harvoni	28 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	28		17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61958-1801	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED HARVONI (LEDIPASVIR AND SOFOSBUVIR) PELLET [GILEAD SCIENCES, INC]	17	Current NDC, Legacy NDC, 1 package rows	20250112_f4ec77e4-bae8-4db0-b3d5-bde09c5fa075.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61958-1801-1	EA - Each	61958-1801	2f24ed0f-b85e-4970-97fc-d1318303cdf2	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LEDIPASVIR	ACTIVE INGREDIENT	013TE6E4WV	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
SOFOSBUVIR	ACTIVE INGREDIENT	WJ6CA3ZU8B	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
LEDIPASVIR	ACTIVE MOIETY	013TE6E4WV	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
SOFOSBUVIR	ACTIVE MOIETY	WJ6CA3ZU8B	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
COPOVIDONE K25-31	INACTIVE INGREDIENT	D9C330MD8B	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	HARVONI (LEDIPASVIR AND SOFOSBUVIR) TABLET, FILM COATED [GILEAD SCIENCES, INC]	4

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 2 of 289 · 5,774 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sweethearts - Ooo La La - Banana Cream Hand Sanitizer	ALCOHOL	Scent Theory Products LLC	5ac34dda-fbdf-0ca7-e063-6394a90ab764	2026-09-05	Warnings	Exact identifier unii: 3K9958V90M
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier unii: 1K09F3G675
Touchland Power Mist Salted Caramel Scented Hydrating Hand sanitizer	ALCOHOL	Church & Dwight Co., Inc.	5aaa5f5b-7a8b-e887-e063-6294a90a9be5	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Peppermint Mocha Scented Hydrating Hand sanitizer	ALCOHOL	Church & Dwight Co., Inc.	5aaa72fe-7667-fb21-e063-6294a90a5e11	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Spiced Pumpkin tini Scented Hydrating Hand sanitizer	ALCOHOL	Church & Dwight Co., Inc.	5aaa809e-71b8-7498-e063-6394a90a9ff8	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Hello Kitty Power Mist Hand Sanitizer Berry Bliss	ALCOHOL	Church & Dwight Co., Inc.	5aaa8d3c-e386-1527-e063-6294a90a07ac	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Cinnamon Gingerbread	ALCOHOL	Church & Dwight Co., Inc.	5aaa9d84-3f84-223e-e063-6294a90a79fb	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Wild Watermelon	ALCOHOL	Church & Dwight Co., Inc.	5aaab1c9-c25c-344a-e063-6294a90a228d	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Confetti Cake	ALCOHOL	Church & Dwight Co., Inc.	5aaacef6-3b8b-ace4-e063-6394a90ab859	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Disney Touchland Power Mist Hydrating Hand Sanitizer Vanilla Blossom	ALCOHOL	Church & Dwight Co., Inc.	5aaae919-4adc-c146-e063-6394a90a8904	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Kuromi Touchland Power Mist Hydrating Hand Sanitizer Cotton Candy	ALCOHOL	Church & Dwight Co., Inc.	5aaaf5a5-d43f-cf23-e063-6394a90a72ef	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Peanuts Touchland Power Mist Hydrating Hand Sanitizer Beach Coco	ALCOHOL	Church & Dwight Co., Inc.	5aaaff8f-5f6b-d575-e063-6394a90a1edc	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Midnight Smores	ALCOHOL	Church & Dwight Co., Inc.	5aab0ca1-b3c4-964f-e063-6294a90a263f	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Touchland Power Mist Hydrating Hand Sanitizer Mist Cranberry Fizz	ALCOHOL	Church & Dwight Co., Inc.	5aab1faa-d884-1a55-e063-6394a90ad6e2	2026-09-04	Warnings	Exact identifier unii: 3K9958V90M
Psoriasis Control	CENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDE	Forces of Nature	2db33771-0bb9-49f8-84fa-dddc28e4ba26	2026-09-04	Warnings	Exact identifier unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPS	POVIDONE, POLYVINYL ALCOHOL SOLUTION	Harrow Eye, LLC	049e9cc9-0663-53bc-e063-6294a90a2c4f	2026-09-04	Warnings	Exact identifier unii: 532B59J990
purelax	POLYETHYLENE GLYCOL 3350	CVS Pharmacy	fc3b6006-a75a-41b3-9f0b-a3152df1363f	2026-09-04	Warnings	Exact identifier unii: G2M7P15E5P
Equate	ETHYL ALCOHOL	Wal-Mart Stores Inc.	ed3796ee-3078-e850-e053-2a95a90a318a	2026-09-03	Warnings	Exact identifier unii: 3K9958V90M
Equate	ETHYL ALCOHOL	Wal-Mart Stores Inc.	ed63bd55-941f-9785-e053-2995a90a5952	2026-09-03	Warnings	Exact identifier unii: 3K9958V90M
basic care clearlax	POLYETHYLENE GLYCOL 3350	Amazon.com Services LLC	1ccb8604-34f6-4e1e-beed-eb81d6aa7aef	2026-09-03	Warnings	Exact identifier unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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