NDC Code(s) : 60758-910-03
Packager : Pacific Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

FLURBIPROFEN SODIUMflurbiprofen sodium SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60758-910
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
flurbiprofen sodium(UNII: Z5B97MU9K4)
(flurbiprofen - UNII:5GRO578KLP) 		flurbiprofen sodium0.3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
thimerosal(UNII: 2225PI3MOV)
citric acid monohydrate(UNII: 2968PHW8QP)
edetate disodium(UNII: 7FLD91C86K)
polyvinyl alcohol(UNII: 532B59J990)
potassium chloride(UNII: 660YQ98I10)
water(UNII: 059QF0KO0R)
sodium chloride(UNII: 451W47IQ8X)
sodium citrate(UNII: 1Q73Q2JULR)
hydrochloric acid(UNII: QTT17582CB)
sodium hydroxide(UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60758-910-031 in 1 CARTON 29/05/1997
12.5 mL in 1 BOTTLE, DROPPER Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA019404 05/29/1997

PRINCIPAL DISPLAY PANEL

PACIFIC
PHARMA ®

NDC 60758-910-03

FLURBIPROFEN
SODIUM
ophthalmic
solution, USP
0.03%

2.5 mL

sterile
Rx only

Carton Label