NDC Code(s) : 11980-801-03
Packager : Allergan, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OCUFENflurbiprofen sodium SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11980-801
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:11980-801-031 in 1 CARTON 01/01/1987
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 NDA019404 01/01/1987

PRINCIPAL DISPLAY PANEL

ALLERGAN

NDC 11980-801-03

Rx Only

OCUFEN®

(flurbiprofen

sodium ophthalmic

solution, USP)

0.03%

sterile

2.5 mL

Carton Label

PRINCIPAL DISPLAY PANEL

ALLERGAN

NDC 11980-801-03 Rx Only

OCUFEN®

(flurbiprofen sodium

ophthalmic solution, USP) 0.03%

2.5 mL sterile

Bottle Label