dorzolamide hydrochloride and timolol maleate

Generic: dorzolamide hydrochloride and timolol maleate preservative free

Labeler: bryant ranch prepack
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 preservative free
Labeler bryant ranch prepack
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-2387
Product ID 72162-2387_62dcb93d-a693-4995-b77e-c1f74c341afa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215936
Listing Expiration 2026-12-31
Marketing Start 2022-02-15

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 721622387
Hyphenated Format 72162-2387

Supplemental Identifiers

RxCUI
1922783
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 preservative free (source: ndc)
Application Number ANDA215936 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

72162-2387-6 4 POUCH in 1 CARTON (72162-2387-6) / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7) / .2 mL in 1 VIAL, SINGLE-USE

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": "62dcb93d-a693-4995-b77e-c1f74c341afa", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1922783"], "spl_set_id": ["cfdc5577-fe7a-4b51-b2f5-95806e1dee2d"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "4 POUCH in 1 CARTON (72162-2387-6)  / 15 VIAL, SINGLE-USE in 1 POUCH (72162-2387-7)  / .2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "72162-2387-6", "marketing_start_date": "20240820"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE", "product_id": "72162-2387_62dcb93d-a693-4995-b77e-c1f74c341afa", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "72162-2387", "generic_name": "DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE", "labeler_name": "Bryant Ranch Prepack", "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": "ANDA215936", "marketing_category": "ANDA", "marketing_start_date": "20220215", "listing_expiration_date": "20261231"}