Dorzolamide Hydrochloride and Timolol Maleate

Product NDC
72162-2184
11-digit product format
721622184
Labeler code
72162
Product ID
72162-2184_2d368eee-4a07-4885-a62d-868ed570e307
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dorzolamide Hydrochloride and Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
Application
ANDA090604
Marketing category
ANDA
Marketing start
2010-01-02
Substance
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
Active strength
20; 5 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
72162-2184-27216221840210 mL in 1 BOTTLE (72162-2184-2) 10 ml2023-12-07NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Dorzolamide Hydrochloride and Timolol MaleateBryant Ranch Prepack2023-12-07HUMAN PRESCRIPTION DRUG LABEL100