Package 81665-204-01
Brand: sodium phenylacetate and sodium benzoate
Generic: sodium phenylacetate and sodium benzoatePackage 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
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"}