dorzolamide hydrochloride ophthalmic

Generic: dorzolamide hydrochloride ophthalmic

Labeler: florida pharmaceutical products, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride ophthalmic
Generic Name dorzolamide hydrochloride ophthalmic
Labeler florida pharmaceutical products, llc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-400
Product ID 71921-400_e4e6a5a8-f7be-4424-83f2-d6bb4d57443e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202053
Listing Expiration 2026-12-31
Marketing Start 2025-05-07

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921400
Hyphenated Format 71921-400

Supplemental Identifiers

RxCUI
310015
UPC
0371921400102
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 ophthalmic (source: ndc)
Generic Name dorzolamide hydrochloride ophthalmic (source: ndc)
Application Number ANDA202053 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE (71921-400-10)
source: ndc

Packages (1)

71921-400-10 10 mL in 1 BOTTLE (71921-400-10)

Ingredients (1)

dorzolamide hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Dorzolamide Hydrochloride Ophthalmic ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "e4e6a5a8-f7be-4424-83f2-d6bb4d57443e", "openfda": {"upc": ["0371921400102"], "unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["e4e6a5a8-f7be-4424-83f2-d6bb4d57443e"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE (71921-400-10)", "package_ndc": "71921-400-10", "marketing_start_date": "20250507"}], "brand_name": "Dorzolamide Hydrochloride Ophthalmic", "product_id": "71921-400_e4e6a5a8-f7be-4424-83f2-d6bb4d57443e", "dosage_form": "SOLUTION", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "71921-400", "generic_name": "Dorzolamide Hydrochloride Ophthalmic", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride Ophthalmic", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA202053", "marketing_category": "ANDA", "marketing_start_date": "20250507", "listing_expiration_date": "20261231"}