dorzolamide hydrochloride

Generic: dorzolamide hydrochloride

Labeler: somerset therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride
Generic Name dorzolamide hydrochloride
Labeler somerset therapeutics, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Somerset Therapeutics, LLC

Identifiers & Regulatory

Product NDC 70069-501
Product ID 70069-501_599cbb55-78b6-467b-8762-fe20c11b013e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215004
Listing Expiration 2026-12-31
Marketing Start 2025-02-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70069501
Hyphenated Format 70069-501

Supplemental Identifiers

RxCUI
310015
UPC
0370069501016
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 ANDA215004 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (70069-501-01) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

70069-501-01 1 BOTTLE in 1 CARTON (70069-501-01) / 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": "599cbb55-78b6-467b-8762-fe20c11b013e", "openfda": {"upc": ["0370069501016"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["0832960f-0a6f-4fd1-bf55-be9bebde53bd"], "manufacturer_name": ["Somerset Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (70069-501-01)  / 10 mL in 1 BOTTLE", "package_ndc": "70069-501-01", "marketing_start_date": "20250212"}], "brand_name": "Dorzolamide Hydrochloride", "product_id": "70069-501_599cbb55-78b6-467b-8762-fe20c11b013e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "70069-501", "generic_name": "Dorzolamide Hydrochloride", "labeler_name": "Somerset Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA215004", "marketing_category": "ANDA", "marketing_start_date": "20250212", "listing_expiration_date": "20261231"}