dorzolamide hydrochloride

Generic: dorzolamide hydrochloride

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

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride
Generic Name dorzolamide hydrochloride
Labeler leading pharma, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Leading Pharma, LLC

Identifiers & Regulatory

Product NDC 69315-304
Product ID 69315-304_74ba8267-62eb-4b2e-a349-400d998a8eb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205294
Listing Expiration 2026-12-31
Marketing Start 2019-12-01

Pharmacologic Class

Classes
carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69315304
Hyphenated Format 69315-304

Supplemental Identifiers

RxCUI
310015
UPC
0369315304105 0369315304051
UNII
QZO5366EW7

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 (source: ndc)
Generic Name dorzolamide hydrochloride (source: ndc)
Application Number ANDA205294 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (69315-304-05) / 5 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (69315-304-10) / 10 mL in 1 BOTTLE
source: ndc

Packages (2)

69315-304-05 1 BOTTLE in 1 CARTON (69315-304-05) / 5 mL in 1 BOTTLE 69315-304-10 1 BOTTLE in 1 CARTON (69315-304-10) / 10 mL in 1 BOTTLE

Ingredients (1)

dorzolamide hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Dorzolamide hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "74ba8267-62eb-4b2e-a349-400d998a8eb8", "openfda": {"upc": ["0369315304105", "0369315304051"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["7d4cb6cd-86d0-41d9-baa9-bca0fa7b0694"], "manufacturer_name": ["Leading Pharma, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (69315-304-05)  / 5 mL in 1 BOTTLE", "package_ndc": "69315-304-05", "marketing_start_date": "20191201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69315-304-10)  / 10 mL in 1 BOTTLE", "package_ndc": "69315-304-10", "marketing_start_date": "20191201"}], "brand_name": "Dorzolamide hydrochloride", "product_id": "69315-304_74ba8267-62eb-4b2e-a349-400d998a8eb8", "dosage_form": "SOLUTION", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "69315-304", "generic_name": "Dorzolamide hydrochloride", "labeler_name": "Leading Pharma, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide hydrochloride", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA205294", "marketing_category": "ANDA", "marketing_start_date": "20191201", "listing_expiration_date": "20261231"}