Dorzolamide Hydrochloride and Timolol Maleate ophthalmic Solution

Product NDC
72162-2381
11-digit product format
721622381
Labeler code
72162
Product ID
72162-2381_0a8b58c2-69be-46f6-8fd1-3b44ceea1283
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
Application
ANDA204777
Marketing category
ANDA
Marketing start
2020-06-15
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
22.3; 6.8 mg/mL; mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [MoA], Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
QZO5366EW7DORZOLAMIDE HYDROCHLORIDE130693-82-2DORZOLAMIDE HYDROCHLORIDE
P8Y54F701RTIMOLOL MALEATE26921-17-5TIMOLOL MALEATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2381-2721622381021 BOTTLE in 1 CARTON (72162-2381-2) / 10 mL in 1 BOTTLE1 bottle2020-06-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dorzolamide Hydrochloride and Timolol Maleate ophthalmic SolutionBryant Ranch Prepack2024-10-09HUMAN PRESCRIPTION DRUG LABEL103