Timolol Maleate Ophthalmic Solution

Timolol Maleate Ophthalmic Solution by

Drug Labeling and Warnings

Timolol Maleate Ophthalmic Solution by is a Prescription medication manufactured, distributed, or labeled by Holopack Verpackungstechnik GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIMOLOL MALEATE OPHTHALMIC SOLUTION- timolol maleate solution 
Holopack Verpackungstechnik GmbH

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Timolol Maleate Ophthalmic Solution

Timolol Maleate Ophthalmic Solution

Timolol Maleate Ophthalmic Solution

Timolol Maleate Ophthalmic Solution

Timolol Maleate Ophthalmic Solution, USP

0.25%

Rx only

NCD Code 69918-602-60

Store at Room Temperature 15-30 ºC (59-86 ºF)

Mfd. For:

Amring Pharmaceuticals Inc.

Berwyn, PA 19312

www.amringusa.com

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01561

EXP 03/2022 LOT TEST02 QTY 30

(17)220331(10)TEST02(30)30

(01)30369918602609(21)123456789012

Printing date: 2022-04-06

Timolol25

Timolol Maleate Ophthalmic Solution, USP

0.5%

Rx only

NCD Code 69918-601-60

Store at Room Temperature 15-30 ºC (59-86 ºF)

Mfd. For:

Amring Pharmaceuticals Inc.

Berwyn, PA 19312

www.amringusa.com

Mfd. By:

Holopack Verpackungstechnik GmbH

Bahnhofstr., 74429 Sulzbach-Laufen

Germany

Holopack Material No.: 011-01561

EXP 03/2022 LOT TEST02 QTY 30

(17)220331(10)TEST02(30)30

(01)30369918601602(21)123456789012

Printing date: 2022-04-06

Timolol50

TIMOLOL MALEATE OPHTHALMIC SOLUTION 
timolol maleate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60940-038
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) TIMOLOL ANHYDROUS5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROMETHAMINE (UNII: 023C2WHX2V)  
BENZODODECINIUM BROMIDE (UNII: IRY12B2TQ6)  
MANNITOL (UNII: 3OWL53L36A)  
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60940-038-016 in 1 CARTON02/04/2022
110 in 1 POUCH
15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21259202/04/2022
TIMOLOL MALEATE OPHTHALMIC SOLUTION 
timolol maleate solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 60940-039
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TIMOLOL MALEATE (UNII: P8Y54F701R) (TIMOLOL ANHYDROUS - UNII:5JKY92S7BR) TIMOLOL ANHYDROUS2.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
TROMETHAMINE (UNII: 023C2WHX2V)  
GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
BENZODODECINIUM BROMIDE (UNII: IRY12B2TQ6)  
MANNITOL (UNII: 3OWL53L36A)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 60940-039-016 in 1 CARTON02/04/2022
110 in 1 POUCH
15 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21259202/04/2022
Labeler - Holopack Verpackungstechnik GmbH (313222457)
Establishment
NameAddressID/FEIBusiness Operations
Holopack Verpackungstechnik GmbH343390324manufacture(60940-039, 60940-038)

Revised: 2/2022
Document Id: d737b1e7-6b7d-1cec-e053-2995a90afe21
Set id: d737b1e7-6b7c-1cec-e053-2995a90afe21
Version: 1
Effective Time: 20220204