Timolol Maleate

Product NDC
50090-7837
11-digit product format
500907837
Labeler code
50090
Product ID
50090-7837_bc369d21-0492-493e-9929-2cae44fd9b9b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Timolol Maleate
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
A-S Medication Solutions
Application
ANDA218460
Marketing category
ANDA
Marketing start
2024-09-16
Substance
TIMOLOL MALEATE
Active strength
5 mg/mL
Pharmacologic classes
Adrenergic beta-Antagonists [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
P8Y54F701RTIMOLOL MALEATE26921-17-5TIMOLOL MALEATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7837-0500907837001 BOTTLE in 1 CARTON (50090-7837-0) / 10 mL in 1 BOTTLE1 bottle2025-12-29NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Timolol Maleate Ophthalmic Solution, USP 0.5% STERILE Rx OnlyA-S Medication Solutions2025-12-30Human Prescription Drug Label1