NDC Code(s) : 61570-037-75
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

VIROPTICtrifluridine SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61570-037
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIFLURIDINE(UNII: RMW9V5RW38)
(TRIFLURIDINE - UNII:RMW9V5RW38) 		TRIFLURIDINE1 g in 100 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:61570-037-751 in 1 CARTON 04/10/1980
17.5 mL in 1 BOTTLE, DROPPER Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018299 04/10/1980

PRINCIPAL DISPLAY PANEL

Drop Dose®
7.5 mL
NDC 61570-037-75

VIROPTIC ® OPHTHALMIC SOLUTION, 1%
(trifluridine ophthalmic solution)
STERILE

Rx only.
STORE UNDER REFRIGERATION 2° to 8°C (36° to 46°F).

Monarch
Pharmaceuticals ®

Distributed by: Monarch
Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: DSM Pharmaceuticals, Inc.,
Greenville, NC 27834

PRINCIPAL DISPLAY PANEL - 7.5 mL Bottle Label

PRINCIPAL DISPLAY PANEL

DROP DOSE®
7.5 mL
NDC 61570-037-75

VIROPTIC ® OPHTHALMIC SOLUTION, 1%
(trifluridine ophthalmic solution)
STERILE

Each mL contains:
Trifluridine 10.0 mg
Thimerosal (preservative) 0.001%

Monarch
Pharmaceuticals ®

Distributed by: Monarch Pharmaceuticals, Inc., Bristol, TN 37620
Manufactured by: DSM Pharmaceuticals, Inc., Greenville, NC 27834

PRINCIPAL DISPLAY PANEL - 7.5 mL Bottle Carton