Package 68475-513-01

Brand: sodium phenylacetate and sodium benzoate

Generic: sodium phenylacetate and sodium benzoate
NDC Package

Package Facts

Identity

Package NDC 68475-513-01
Digits Only 6847551301
Product NDC 68475-513
Description

1 VIAL in 1 CARTON (68475-513-01) / 20 mL in 1 VIAL

Marketing

Marketing Status
Marketed Since 2025-12-06
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": "1c41d0b4-cb49-468a-a9f3-6eeb22dd836f", "openfda": {"upc": ["0368475513013"], "unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["2560228"], "spl_set_id": ["d20768fe-4516-483a-a082-ff1df9ad1d99"], "manufacturer_name": ["Navinta LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68475-513-01)  / 20 mL in 1 VIAL", "package_ndc": "68475-513-01", "marketing_start_date": "20251206"}], "brand_name": "Sodium phenylacetate and Sodium benzoate", "product_id": "68475-513_1c41d0b4-cb49-468a-a9f3-6eeb22dd836f", "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": "68475-513", "generic_name": "Sodium phenylacetate and Sodium benzoate", "labeler_name": "Navinta 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": "ANDA217526", "marketing_category": "ANDA", "marketing_start_date": "20251206", "listing_expiration_date": "20261231"}