dorzolamide hydrochloride and timolol maleate

Generic: dorzolamide hydrochloride and timolol maleate

Labeler: ingenus pharmaceuticals, llc
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 ingenus pharmaceuticals, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-323
Product ID 50742-323_d2b2581d-16f3-468d-b0aa-657747142287
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA217260
Listing Expiration 2026-12-31
Marketing Start 2023-05-02

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 50742323
Hyphenated Format 50742-323

Supplemental Identifiers

RxCUI
1922783
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 ANDA217260 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL
source: ndc

Packages (1)

50742-323-60 12 POUCH in 1 CARTON (50742-323-60) / 5 VIAL in 1 POUCH (50742-323-05) / .2 mL in 1 VIAL

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": "d2b2581d-16f3-468d-b0aa-657747142287", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1922783"], "spl_set_id": ["36c0e765-dfda-4b3b-8a98-a5f8b32607f7"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (50742-323-60)  / 5 VIAL in 1 POUCH (50742-323-05)  / .2 mL in 1 VIAL", "package_ndc": "50742-323-60", "marketing_start_date": "20230502"}], "brand_name": "Dorzolamide hydrochloride and timolol maleate", "product_id": "50742-323_d2b2581d-16f3-468d-b0aa-657747142287", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "50742-323", "generic_name": "Dorzolamide hydrochloride and timolol maleate", "labeler_name": "Ingenus Pharmaceuticals, 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": "ANDA217260", "marketing_category": "ANDA", "marketing_start_date": "20230502", "listing_expiration_date": "20261231"}