Package 82604-600-00

Brand: omidria

Generic: phenylephrine and ketorolac
NDC Package

Package Facts

Identity

Package NDC 82604-600-00
Digits Only 8260460000
Product NDC 82604-600
Description

1 VIAL in 1 CARTON (82604-600-00) / 4 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2023-07-01
Brand omidria
Generic phenylephrine and ketorolac
Sample Package No

Linked Drug Pages (0)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAOCULAR"], "spl_id": "ffe62883-85a4-6e94-e053-6294a90ac61f", "openfda": {"nui": ["N0000000160", "M0001335", "N0000175722", "N0000175939", "N0000186105", "N0000009917"], "unii": ["YZI5105V0L", "1WS297W6MV"], "rxcui": ["1540230", "1540235"], "spl_set_id": ["f25d7a42-da2a-7310-e053-2995a90a590f"], "pharm_class_cs": ["Anti-Inflammatory Agents, Non-Steroidal [CS]"], "pharm_class_epc": ["Nonsteroidal Anti-inflammatory Drug [EPC]", "Cyclooxygenase Inhibitor [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Cyclooxygenase Inhibitors [MoA]", "Adrenergic alpha1-Agonists [MoA]"], "manufacturer_name": ["Rayner Surgical Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (82604-600-00)  / 4 mL in 1 VIAL", "package_ndc": "82604-600-00", "marketing_start_date": "20230701"}, {"sample": false, "description": "4 VIAL in 1 CARTON (82604-600-04)  / 4 mL in 1 VIAL", "package_ndc": "82604-600-04", "marketing_start_date": "20230701"}, {"sample": true, "description": "4 VIAL in 1 CARTON (82604-600-99)  / 4 mL in 1 VIAL", "package_ndc": "82604-600-99", "marketing_start_date": "20230701"}], "brand_name": "Omidria", "product_id": "82604-600_ffe62883-85a4-6e94-e053-6294a90ac61f", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Anti-Inflammatory Agents", "Non-Steroidal [CS]", "Cyclooxygenase Inhibitor [EPC]", "Cyclooxygenase Inhibitors [MoA]", "Nonsteroidal Anti-inflammatory Drug [EPC]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "82604-600", "generic_name": "phenylephrine and ketorolac", "labeler_name": "Rayner Surgical Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Omidria", "active_ingredients": [{"name": "KETOROLAC", "strength": "2.88 mg/mL"}, {"name": "PHENYLEPHRINE", "strength": "10.16 mg/mL"}], "application_number": "NDA205388", "marketing_category": "NDA", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}