DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product NDC
72162-2387
11-digit product format
721622387
Labeler code
72162
Product ID
72162-2387_62dcb93d-a693-4995-b77e-c1f74c341afa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bryant Ranch Prepack
Application
ANDA215936
Marketing category
ANDA
Marketing start
2022-02-15
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
72162-2387-6721622387064 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE4 pouch2024-08-20NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEBryant Ranch Prepack2024-08-20HUMAN PRESCRIPTION DRUG LABEL100