cosopt

Generic: dorzolamide hydrochloride and timolol maleate

Labeler: thea pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cosopt
Generic Name dorzolamide hydrochloride and timolol maleate
Labeler thea pharma inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Thea Pharma Inc.

Identifiers & Regulatory

Product NDC 82584-605
Product ID 82584-605_164c0ca8-87af-0887-e063-6294a90a5ec7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020869
Listing Expiration 2026-12-31
Marketing Start 2022-11-10

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 82584605
Hyphenated Format 82584-605

Supplemental Identifiers

RxCUI
1923432 1923433
UPC
0382584605100
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 cosopt (source: ndc)
Generic Name dorzolamide hydrochloride and timolol maleate (source: ndc)
Application Number NDA020869 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

82584-605-10 1 BOTTLE, DROPPER in 1 CARTON (82584-605-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (2)

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

Linked Drug Pages (1)

COSOPT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "164c0ca8-87af-0887-e063-6294a90a5ec7", "openfda": {"upc": ["0382584605100"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432", "1923433"], "spl_set_id": ["23bdf1c1-3134-4ad1-8e7c-bc655156bdc6"], "manufacturer_name": ["Thea Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82584-605-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "82584-605-10", "marketing_start_date": "20221110"}], "brand_name": "COSOPT", "product_id": "82584-605_164c0ca8-87af-0887-e063-6294a90a5ec7", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "82584-605", "generic_name": "dorzolamide hydrochloride and timolol maleate", "labeler_name": "Thea Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "COSOPT", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "NDA020869", "marketing_category": "NDA", "marketing_start_date": "20221110", "listing_expiration_date": "20261231"}