dorzolamide hydrochloride

Generic: dorzolamide hydrochloride

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride
Generic Name dorzolamide hydrochloride
Labeler sandoz inc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-019
Product ID 61314-019_764fec18-11c4-4320-a834-83c80c7040d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078981
Listing Expiration 2026-12-31
Marketing Start 2009-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314019
Hyphenated Format 61314-019

Supplemental Identifiers

RxCUI
310015
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 ANDA078981 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE (61314-019-10)
source: ndc

Packages (1)

61314-019-10 10 mL in 1 BOTTLE (61314-019-10)

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": "764fec18-11c4-4320-a834-83c80c7040d2", "openfda": {"unii": ["QZO5366EW7"], "rxcui": ["310015"], "spl_set_id": ["29157995-fa61-4425-86a5-5bd0e4718cd8"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE (61314-019-10)", "package_ndc": "61314-019-10", "marketing_start_date": "20090601"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE", "product_id": "61314-019_764fec18-11c4-4320-a834-83c80c7040d2", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]"], "product_ndc": "61314-019", "generic_name": "dorzolamide hydrochloride", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DORZOLAMIDE HYDROCHLORIDE", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA078981", "marketing_category": "ANDA", "marketing_start_date": "20090601", "listing_expiration_date": "20261231"}