dorzolamide and timolol

Generic: dorzolamide hydrochloride and timolol maleate ophthalmic solution

Labeler: leading pharma, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide and timolol
Generic Name dorzolamide hydrochloride and timolol maleate ophthalmic solution
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-305
Product ID 69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205295
Listing Expiration 2026-12-31
Marketing Start 2017-05-18

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 69315305
Hyphenated Format 69315-305

Supplemental Identifiers

RxCUI
1923432
UPC
0369315305058 0369315305102
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 and timolol (source: ndc)
Generic Name dorzolamide hydrochloride and timolol maleate ophthalmic solution (source: ndc)
Application Number ANDA205295 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (2)

69315-305-05 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05) / 5 mL in 1 BOTTLE, PLASTIC 69315-305-10 1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10) / 10 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

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

Linked Drug Pages (1)

Dorzolamide and Timolol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "bb4ef754-0b95-4c0e-8131-7a81dc4f33d3", "openfda": {"upc": ["0369315305058", "0369315305102"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["c9ae08c5-275d-44b3-9d1e-5d8fedc21b96"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69315-305-05)  / 5 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69315-305-05", "marketing_start_date": "20170518"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (69315-305-10)  / 10 mL in 1 BOTTLE, PLASTIC", "package_ndc": "69315-305-10", "marketing_start_date": "20170518"}], "brand_name": "Dorzolamide and Timolol", "product_id": "69315-305_bb4ef754-0b95-4c0e-8131-7a81dc4f33d3", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "69315-305", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide and Timolol", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA205295", "marketing_category": "ANDA", "marketing_start_date": "20170518", "listing_expiration_date": "20261231"}