NDC Code(s) : 0037-7025-60
Packager : Meda Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

OptivarAzelastine Hydrochloride SOLUTION/ DROPS
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0037-7025
Route of Administration INTRAOCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZELASTINE HYDROCHLORIDE(UNII: 0L591QR10I)
(AZELASTINE - UNII:ZQI909440X) 		AZELASTINE HYDROCHLORIDE0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE(UNII: F5UM2KM3W7)125 ug in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0037-7025-601 in 1 BOX
16 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021127 05/22/2000

PRINCIPAL DISPLAY PANEL

NDC 0037-7025-60

OPTIVAR ®

azelastine hydrochloride
ophthalmic solution, 0.05%

Rx Only     6 mL – Sterile

Usual dosage: 1 drop per affected eye(s) twice daily.
See package insert for full prescribing information.
STORE UPRIGHT between 2° and 25°C (36° and 77°F).

U.S. Patent 5,164,194
Mfd by: Patheon UK Ltd. Swindon, United Kingdom

Dist by:
MEDA Pharmaceuticals ®
Meda Pharmaceuticals Inc.
Somerset, New Jersey 08873-4120

OTD 90941

Rev. 4/09

Made in United Kingdom

Exp. Date
Lot No.

6 mL Bottle