NDC product

Harvoni

NDC 61958-1804 · Gilead Sciences, Inc

Key facts

Product NDC 61958-1804
Proprietary name Harvoni
Nonproprietary name ledipasvir and sofosbuvir
Substances LEDIPASVIR, SOFOSBUVIR
Dosage form PELLET
Route ORAL
Labeler Gilead Sciences, Inc
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA212477
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Hepatitis C Virus NS5A Inhibitor [EPC], Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor [EPC], P-Glycoprotein Inhibitors [MoA], RNA Replicase Inhibitors [MoA]
Marketing start Aug 28, 2019
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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