dorzolamide hydrochloride and timolol maleate

Generic: dorzolamide hydrochloride and timolol maleate

Labeler: genus lifesciences
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate
Generic Name dorzolamide hydrochloride and timolol maleate
Labeler genus lifesciences
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Genus Lifesciences

Identifiers & Regulatory

Product NDC 64950-390
Product ID 64950-390_4a9014f4-6011-4b1a-9039-f8ec141a6d98
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216308
Listing Expiration 2026-12-31
Marketing Start 2025-08-01

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 64950390
Hyphenated Format 64950-390

Supplemental Identifiers

RxCUI
1923432
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 ANDA216308 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 60 VIAL, SINGLE-DOSE in 1 CARTON (64950-390-60) / .2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

64950-390-60 60 VIAL, SINGLE-DOSE in 1 CARTON (64950-390-60) / .2 mL in 1 VIAL, SINGLE-DOSE

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": "4a9014f4-6011-4b1a-9039-f8ec141a6d98", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["3b3a4716-1082-4a7a-bf5a-2e2bac38dfbc"], "manufacturer_name": ["Genus Lifesciences"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 VIAL, SINGLE-DOSE in 1 CARTON (64950-390-60)  / .2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "64950-390-60", "marketing_start_date": "20250801"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "64950-390_4a9014f4-6011-4b1a-9039-f8ec141a6d98", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "64950-390", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "Genus Lifesciences", "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": "ANDA216308", "marketing_category": "ANDA", "marketing_start_date": "20250801", "listing_expiration_date": "20261231"}