Package 68083-490-01
Brand: dorzolamide hydrochloride and timolol maleate
Generic: dorzolamide hydrochloride and timolol maleatePackage 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
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"}