dorzolamide hydrochloride and timolol maleate (70069-051)

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate

Generic Name dorzolamide hydrochloride and timolol maleate

Labeler somerset therapeutics, llc

Dosage Form SOLUTION

Routes

OPHTHALMIC

Active Ingredients

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

Manufacturer

Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-051

Product ID 70069-051_81a3be92-0fdb-46c8-bc20-cd0947a2dbdf

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA207523

Listing Expiration 2026-12-31

Marketing Start 2019-06-25

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 70069051

Hyphenated Format 70069-051

Supplemental Identifiers

RxCUI

1923432

UPC

0370069051016

UNII

QZO5366EW7 P8Y54F701R

Packaging Origin

Original Packager

true

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 ANDA207523 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

20 mg/mL
5 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE

source: ndc

Packages (1)

70069-051-01 1 BOTTLE in 1 CARTON (70069-051-01) / 10 mL in 1 BOTTLE

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": "81a3be92-0fdb-46c8-bc20-cd0947a2dbdf", "openfda": {"upc": ["0370069051016"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["17f04726-725f-4839-911d-47fc5e02baae"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-051-01)  / 10 mL in 1 BOTTLE", "package_ndc": "70069-051-01", "marketing_start_date": "20190625"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE", "product_id": "70069-051_81a3be92-0fdb-46c8-bc20-cd0947a2dbdf", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "70069-051", "generic_name": "DORZOLAMIDE HYDROCHLORIDE and TIMOLOL MALEATE", "labeler_name": "Somerset Therapeutics, LLC", "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": "ANDA207523", "marketing_category": "ANDA", "marketing_start_date": "20190625", "listing_expiration_date": "20261231"}