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These highlights do not include all the information needed to use LEDIPASVIR and SOFOSBUVIR TABLETS safely and effectively. See full prescribing information for LEDIPASVIR and SOFOSBUVIR TABLETS. LEDIPASVIR and SOFOSBUVIR tablets, for oral use, 90 mg/400 mg (Authorized generic of HARVONI®) Initial U.S. Approval: 2014
Medication labelWhy this: Advisory · dailymed-prescription
Ledipasvir and sofosbuvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) [see Dosage and Administration (2.2 and 2.3) and Clinical Studies (14)]: genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
- generic_name
- ledipasvir and sofosbuvir
- product_names
- Ledipasvir and Sofosbuvir
- ndc
- 72626-2601, 72626-2601-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en