Sofosbuvir and Velpatasvir (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 14 Tablet Blister Card Carton

NDC 72626-2701-1

ASEGUA™
THERAPEUTICS

Sofosbuvir and Velpatasvir
400 mg/100 mg
tablets
Take 1 tablet once daily

Rx only

Note to pharmacist:
Do not cover ALERT box with pharmacy label.

ALERT: Find out about medicines that should
NOT be taken with Sofosbuvir and Velpatasvir

Contents:28 tablets: Two blister cards containing 14 tablets per blister card

Authorized generic of Epclusa®

PRINCIPAL DISPLAY PANEL -- 14 Tablet Blister Card Carton
(click image for full-size original)
SOFOSBUVIR AND VELPATASVIR velpatasvir and sofosbuvir tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72626-2701
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VELPATASVIR (VELPATASVIR) VELPATASVIR 100 mg
SOFOSBUVIR (SOFOSBUVIR) SOFOSBUVIR 400 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
COPOVIDONE K25-31
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
WATER
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 3350
TALC
FERRIC OXIDE RED
POLYVINYL ALCOHOL, UNSPECIFIED
Product Characteristics
Color PINK Score no score
Shape DIAMOND Size 20mm
Flavor Imprint Code ASE;9761
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72626-2701-1 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (72626-2701-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA208341 11/14/2018
Labeler — Asegua Therapeutics LLC (116670954)

Revised: 05/2022 Asegua Therapeutics LLC

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