Package 81665-204-01

Brand: sodium phenylacetate and sodium benzoate

Generic: sodium phenylacetate and sodium benzoate
NDC Package

Package Facts

Identity

Package NDC 81665-204-01
Digits Only 8166520401
Product NDC 81665-204
Description

1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Marketing

Marketing Status
Marketed Since 2025-05-15
Brand sodium phenylacetate and sodium benzoate
Generic sodium phenylacetate and sodium benzoate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "03dcc78e-b47c-46dc-b7be-b6e6dcb0d071", "openfda": {"unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["984118"], "spl_set_id": ["8fafc39b-69db-40f3-8a09-ee859e8cef19"], "manufacturer_name": ["Omnivium Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (81665-204-01)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "81665-204-01", "marketing_start_date": "20250515"}], "brand_name": "SODIUM PHENYLACETATE and SODIUM BENZOATE", "product_id": "81665-204_03dcc78e-b47c-46dc-b7be-b6e6dcb0d071", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["Ammonium Ion Binding Activity [MoA]", "Ammonium Ion Binding Activity [MoA]", "Nitrogen Binding Agent [EPC]", "Nitrogen Binding Agent [EPC]"], "product_ndc": "81665-204", "generic_name": "sodium phenylacetate and sodium benzoate", "labeler_name": "Omnivium Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SODIUM PHENYLACETATE and SODIUM BENZOATE", "active_ingredients": [{"name": "SODIUM BENZOATE", "strength": "100 mg/mL"}, {"name": "SODIUM PHENYLACETATE", "strength": "100 mg/mL"}], "application_number": "ANDA207096", "marketing_category": "ANDA", "marketing_start_date": "20250515", "listing_expiration_date": "20261231"}