Timoptic in Ocudose (Page 4 of 4)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 69918-601- 60
Rx only

Timolol Maleate Ophthalmic Solution, USP

0.5%*

For Topical Application In The Eye

Preservative-Free Sterile Ophthalmic Solution

Keep out of reach of children.

60 x 0.3 mL Single-dose Vials

timo carton .25
(click image for full-size original)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 69918-601- 60
Rx only

Timolol Maleate Ophthalmic Solution, USP

0.5%*

For Topical Application In The Eye

Preservative-Free Sterile Ophthalmic Solution

Keep out of reach of children.

10 x 0.3 mL Single-dose Vials

timo Foil .25
(click image for full-size original)
TIMOPTIC IN OCUDOSE timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69918-602
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIMOLOL MALEATE (TIMOLOL ANHYDROUS) TIMOLOL ANHYDROUS 2.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69918-602-60 60 POUCH in 1 CARTON contains a POUCH
1 10 CONTAINER in 1 POUCH This package is contained within the CARTON (69918-602-60) and contains a CONTAINER
1 0.3 mL in 1 CONTAINER This package is contained within a POUCH and a CARTON (69918-602-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212592 02/26/2022
TIMOPTIC IN OCUDOSE timolol maleate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69918-601
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TIMOLOL MALEATE (TIMOLOL ANHYDROUS) TIMOLOL ANHYDROUS 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69918-601-60 60 POUCH in 1 CARTON contains a POUCH
1 10 CONTAINER in 1 POUCH This package is contained within the CARTON (69918-601-60) and contains a CONTAINER
1 0.3 mL in 1 CONTAINER This package is contained within a POUCH and a CARTON (69918-601-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212592 02/26/2022
Labeler — Amring Pharmaceuticals Inc. (079843051)
Establishment
Name Address ID/FEI Operations
Holopack Verpackungstechnik GmbH 343390324 MANUFACTURE (69918-602), MANUFACTURE (69918-601), PACK (69918-602), PACK (69918-601)

Revised: 12/2021 Amring Pharmaceuticals Inc.

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