dorzolamide hydrochloride timolol maleate

Generic: dorzolamide hydrochloride timolol maleate

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

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride timolol maleate
Generic Name dorzolamide hydrochloride timolol maleate
Labeler florida pharmaceutical products, llc
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dorzolamide hydrochloride 20 mg/mL, timolol maleate 5 mg/mL

Manufacturer
Florida Pharmaceutical Products, LLC

Identifiers & Regulatory

Product NDC 71921-226
Product ID 71921-226_3b805f74-957a-4a13-8066-94aed2ed4f10
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202054
Listing Expiration 2027-12-31
Marketing Start 2023-08-16

Pharmacologic Class

Classes
adrenergic beta-antagonists [moa] carbonic anhydrase inhibitor [epc] carbonic anhydrase inhibitors [moa] beta-adrenergic blocker [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71921226
Hyphenated Format 71921-226

Supplemental Identifiers

RxCUI
1923432
UPC
0371921226108
UNII
QZO5366EW7 P8Y54F701R

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 timolol maleate (source: ndc)
Generic Name dorzolamide hydrochloride timolol maleate (source: ndc)
Application Number ANDA202054 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DISPENSING in 1 CARTON (71921-226-10) / 10 mL in 1 BOTTLE, DISPENSING
source: ndc

Packages (1)

71921-226-10 1 BOTTLE, DISPENSING in 1 CARTON (71921-226-10) / 10 mL in 1 BOTTLE, DISPENSING

Ingredients (2)

dorzolamide hydrochloride (20 mg/mL) timolol maleate (5 mg/mL)

Linked Drug Pages (1)

DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3b805f74-957a-4a13-8066-94aed2ed4f10", "openfda": {"upc": ["0371921226108"], "unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["02d89d37-cbca-4e06-83ef-2a10f988f1ea"], "manufacturer_name": ["Florida Pharmaceutical Products, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DISPENSING in 1 CARTON (71921-226-10)  / 10 mL in 1 BOTTLE, DISPENSING", "package_ndc": "71921-226-10", "marketing_start_date": "20230816"}], "brand_name": "DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE", "product_id": "71921-226_3b805f74-957a-4a13-8066-94aed2ed4f10", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "71921-226", "generic_name": "dorzolamide hydrochloride timolol maleate", "labeler_name": "Florida Pharmaceutical Products, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DORZOLAMIDE HYDROCHLORIDE TIMOLOL MALEATE", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA202054", "marketing_category": "ANDA", "marketing_start_date": "20230816", "listing_expiration_date": "20271231"}