61958-1801 : Harvoni Oral Tablet, Film Coated

NDC:	61958-1801
Labeler:	Gilead Sciences, Inc
Product Type:	Human Prescription Drug
Drug Name:	Harvoni
Dosage Form:	Oral Tablet, Film Coated
Application #:	NDA205834
Rev. Date:	Oct 10, 2014

Appearance:

Markings:	GSI;7985
Shapes:	Diamond (4 sides)
Colors:	Orange
Size (mm):	20
Segments: ^*	1
^* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

GSI 7985: (61958-1801) Harvoni Oral Tablet, Film Coated by Gilead Sciences, Inc

The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

61958-1801-1: 28 TABLET, FILM COATED IN 1 BOTTLE, PLASTIC (61958‑1801‑1)

Active Ingredients:

Ledipasvir
Sofosbuvir

Dosage Strength:

90 mg
400 mg

Inactive Ingredients:

Alcohol
Copovidone K25-31
Lactose Monohydrate
Cellulose, Microcrystalline
Silicon Dioxide
Croscarmellose Sodium
Magnesium Stearate
Water
Titanium Dioxide
Polyethylene Glycol 3350
Talc
Fd&c Yellow No. 6
Polyvinyl Alcohol

Pharmaceutical Classes:

Hepatitis C Virus NS5A Inhibitor [EPC]
P-Glycoprotein Inhibitors [MoA]
Breast Cancer Resistance Protein Inhibitors [MoA]
Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC]
RNA Replicase Inhibitors [MoA]
Nucleoside Analog [Chemical/Ingredient]

NDC QR Code

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NDC 61958-1801 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.