dorzolamide hydrochloride and timolol maleate (50090-6371)

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate

Generic Name dorzolamide hydrochloride and timolol maleate

Labeler a-s medication solutions

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

dorzolamide hydrochloride 20 mg/mL, timolol maleate 5 mg/mL

Manufacturer

A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6371

Product ID 50090-6371_0e21f8dd-6fb3-4150-a6c0-a9c20aee8fdf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090037

Listing Expiration 2026-12-31

Marketing Start 2009-07-14

Pharmacologic Class

Classes

adrenergic beta-antagonists [moa] carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500906371

Hyphenated Format 50090-6371

Supplemental Identifiers

RxCUI

1923432

UNII

QZO5366EW7 P8Y54F701R

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dorzolamide hydrochloride and timolol maleate (source: ndc)

Generic Name dorzolamide hydrochloride and timolol maleate (source: ndc)

Application Number ANDA090037 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

20 mg/mL
5 mg/mL

source: ndc

Packaging

1 BOTTLE, DROPPER in 1 CARTON (50090-6371-0) / 10 mL in 1 BOTTLE, DROPPER

source: ndc

Packages (1)

50090-6371-0 1 BOTTLE, DROPPER in 1 CARTON (50090-6371-0) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (2)

dorzolamide hydrochloride (20 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

Dorzolamide Hydrochloride and Timolol Maleate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "0e21f8dd-6fb3-4150-a6c0-a9c20aee8fdf", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["8cdf22c8-75ca-404e-b354-9e254690d0e7"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-6371-0)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-6371-0", "marketing_start_date": "20230213"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "50090-6371_0e21f8dd-6fb3-4150-a6c0-a9c20aee8fdf", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50090-6371", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride and Timolol Maleate", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA090037", "marketing_category": "ANDA", "marketing_start_date": "20090714", "listing_expiration_date": "20261231"}