NDC Code(s) : 0006-3931-10, 0006-3931-30, 0006-3931-54, 0006-3931-36
Packager : Merck Sharp & Dohme Corp.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ZIOPTANTAFLUPROST SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0006-3931
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAFLUPROST(UNII: 1O6WQ6T7G3)
(TAFLUPROST - UNII:1O6WQ6T7G3) 		TAFLUPROST0.0045 mg in 0.3 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE(UNII: 5QWK665956)
GLYCERIN(UNII: PDC6A3C0OX)
EDETATE DISODIUM(UNII: 7FLD91C86K)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0006-3931-303 in 1 CARTON
1NDC:0006-3931-549 in 1 CARTON
1NDC:0006-3931-1010 in 1 POUCH
10.3 mL in 1 AMPULE
2NDC:0006-3931-361 in 1 CARTON
210 in 1 POUCH
20.3 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA202514 02/10/2012

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 Ampule Carton

NDC 0006-3931-30

ZIOPTAN™
(tafluprost ophthalmic
solution)
0.0015%

For Topical Application in the Eye
REFRIGERATE (2-8°C or 36-46°F)

Single-Use Containers
Preservative-Free, Sterile

Contains:
Active: tafluprost 0.0015%
(4.5 mcg per single-use container)
Inactive ingredients: glycerol, sodium dihydrogen
phosphate dihydrate, disodium edetate, polysorbate 80,
Water for Injection. Hydrochloric acid and/or
sodium hydroxide are added to adjust pH.

Rx only
30 Single-Use Containers:
3 pouches × 10 single-use containers
(0.3 mL each)

6010903

Principal Display Panel - 30 Ampule Carton