dorzolamide hydrochloride

Generic: dorzolamide hydrochloride

Labeler: advagen pharma ltd.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride
Generic Name dorzolamide hydrochloride
Labeler advagen pharma ltd.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Advagen Pharma Ltd.

Identifiers & Regulatory

Product NDC 72888-077
Product ID 72888-077_2f317fdd-3f6d-bc0e-e063-6294a90aa300
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078395
Listing Expiration 2026-12-31
Marketing Start 2024-12-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888077
Hyphenated Format 72888-077

Supplemental Identifiers

RxCUI
310015
UPC
0372888077154
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 ANDA078395 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72888-077-15) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

72888-077-15 1 BOTTLE in 1 CARTON (72888-077-15) / 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": "2f317fdd-3f6d-bc0e-e063-6294a90aa300", "openfda": {"upc": ["0372888077154"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["ed9d1658-43cc-4c78-b3d8-e7d980a6b673"], "manufacturer_name": ["Advagen Pharma Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72888-077-15)  / 10 mL in 1 BOTTLE", "package_ndc": "72888-077-15", "marketing_start_date": "20241223"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE", "product_id": "72888-077_2f317fdd-3f6d-bc0e-e063-6294a90aa300", "dosage_form": "SOLUTION", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "72888-077", "generic_name": "dorzolamide hydrochloride", "labeler_name": "Advagen Pharma Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DORZOLAMIDE HYDROCHLORIDE", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA078395", "marketing_category": "ANDA", "marketing_start_date": "20241223", "listing_expiration_date": "20261231"}