dorzolamide hydrochloride and timolol maleate ophthalmic solution

Generic: dorzolamide hydrochloride and timolol maleate ophthalmic solution

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dorzolamide hydrochloride and timolol maleate ophthalmic solution
Generic Name dorzolamide hydrochloride and timolol maleate ophthalmic solution
Labeler alembic pharmaceuticals limited
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

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

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-553
Product ID 46708-553_2b1fa44a-3890-4634-bcfc-c7310b51128e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213099
Listing Expiration 2026-12-31
Marketing Start 2021-05-04

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 46708553
Hyphenated Format 46708-553

Supplemental Identifiers

RxCUI
1923432
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 and timolol maleate ophthalmic solution (source: ndc)
Generic Name dorzolamide hydrochloride and timolol maleate ophthalmic solution (source: ndc)
Application Number ANDA213099 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
  • 5 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (46708-553-10) / 10 mL in 1 BOTTLE
source: ndc

Packages (1)

46708-553-10 1 BOTTLE in 1 CARTON (46708-553-10) / 10 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2b1fa44a-3890-4634-bcfc-c7310b51128e", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["2b1fa44a-3890-4634-bcfc-c7310b51128e"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (46708-553-10)  / 10 mL in 1 BOTTLE", "package_ndc": "46708-553-10", "marketing_start_date": "20210504"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution", "product_id": "46708-553_2b1fa44a-3890-4634-bcfc-c7310b51128e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "46708-553", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA213099", "marketing_category": "ANDA", "marketing_start_date": "20210504", "listing_expiration_date": "20261231"}