NDC Code(s) : 25010-816-56, 25010-817-56
Packager : Aton Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Timolol MaleateTimolol Maleate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25010-816
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Timolol Maleate(UNII: P8Y54F701R)
(TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) 		TIMOLOL ANHYDROUS2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GELLAN GUM (LOW ACYL)(UNII: 7593U09I4D)
Tromethamine(UNII: 023C2WHX2V)
Mannitol(UNII: 3OWL53L36A)
Water(UNII: 059QF0KO0R)
Benzododecinium Bromide(UNII: IRY12B2TQ6)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:25010-816-561 in 1 CARTON
15 mL in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020330 10/15/2009
Timolol MaleateTimolol Maleate SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25010-817
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Timolol Maleate(UNII: P8Y54F701R)
(TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) 		TIMOLOL ANHYDROUS5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
GELLAN GUM (LOW ACYL)(UNII: 7593U09I4D)
Tromethamine(UNII: 023C2WHX2V)
Mannitol(UNII: 3OWL53L36A)
Water(UNII: 059QF0KO0R)
Benzododecinium Bromide(UNII: IRY12B2TQ6)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:25010-817-561 in 1 CARTON
15 mL in 1 BOTTLE, DISPENSING Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020330 11/14/1993

PRINCIPAL DISPLAY PANEL

Rx only

NDC 25010-816-56

TIMOLOL MALEATE
OPHTHALMIC GEL
FORMING SOLUTION

0.25%

Timolol Equivalent
(Timolol Maleate 3.4 mg/mL)

5 mL

OCUMETER® PLUS
OPHTHALMIC DISPENSER
STERILE OPHTHALMIC
GEL FORMING SOLUTION

VALEANT®

Ophthalmics

Made in France

Rev. 07/12

70009234

Timolol Maleate 0.25 Carton

PRINCIPAL DISPLAY PANEL

Rx only

NDC 25010-817-56

TIMOLOL MALEATE
OPHTHALMIC GEL
FORMING SOLUTION

0.5%

Timolol Equivalent
(Timolol Maleate 6.8 mg/mL)

5 mL

OCUMETER® PLUS
OPHTHALMIC DISPENSER
STERILE OPHTHALMIC
GEL FORMING SOLUTION

VALEANT®

Ophthalmics

Made in France

Rev. 07/12

70009237

Timolol Maleate 0.5 Carton