Package 68083-490-01

Brand: dorzolamide hydrochloride and timolol maleate

Generic: dorzolamide hydrochloride and timolol maleate
NDC Package

Package Facts

Identity

Package NDC 68083-490-01
Digits Only 6808349001
Product NDC 68083-490
Description

1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE

Marketing

Marketing Status
Marketed Since 2022-09-19
Brand dorzolamide hydrochloride and timolol maleate
Generic dorzolamide hydrochloride and timolol maleate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "669669a0-0268-4fc0-b73b-7ceeaaea529e", "openfda": {"unii": ["QZO5366EW7", "P8Y54F701R"], "rxcui": ["1923432"], "spl_set_id": ["efab039e-a69d-4306-8305-b1d27781cfe0"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68083-490-01)  / 10 mL in 1 BOTTLE", "package_ndc": "68083-490-01", "marketing_start_date": "20220919"}], "brand_name": "Dorzolamide Hydrochloride and Timolol Maleate", "product_id": "68083-490_669669a0-0268-4fc0-b73b-7ceeaaea529e", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Adrenergic beta-Antagonists [MoA]", "Carbonic Anhydrase Inhibitor [EPC]", "Carbonic Anhydrase Inhibitors [MoA]", "beta-Adrenergic Blocker [EPC]"], "product_ndc": "68083-490", "generic_name": "Dorzolamide Hydrochloride and Timolol Maleate", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dorzolamide Hydrochloride and Timolol Maleate", "active_ingredients": [{"name": "DORZOLAMIDE HYDROCHLORIDE", "strength": "20 mg/mL"}, {"name": "TIMOLOL MALEATE", "strength": "5 mg/mL"}], "application_number": "ANDA215520", "marketing_category": "ANDA", "marketing_start_date": "20220919", "listing_expiration_date": "20261231"}