Package 68382-396-01
Brand: sodium phenylacetate and sodium benzoate
Generic: sodium phenylacetate and sodium benzoatePackage Facts
Identity
Package NDC
68382-396-01
Digits Only
6838239601
Product NDC
68382-396
Description
1 VIAL in 1 CARTON (68382-396-01) / 50 mL in 1 VIAL
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": "6ad04728-e1b6-4851-9614-1322607ce238", "openfda": {"upc": ["0368382396013"], "unii": ["OJ245FE5EU", "48N6U1781G"], "rxcui": ["984118"], "spl_set_id": ["204e84a7-5440-4537-9e40-06eb56c415e9"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68382-396-01) / 50 mL in 1 VIAL", "package_ndc": "68382-396-01", "marketing_start_date": "20210208"}], "brand_name": "SODIUM PHENYLACETATE AND SODIUM BENZOATE", "product_id": "68382-396_6ad04728-e1b6-4851-9614-1322607ce238", "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": "68382-396", "generic_name": "sodium phenylacetate and sodium benzoate", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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": "ANDA205880", "marketing_category": "ANDA", "marketing_start_date": "20210208", "listing_expiration_date": "20261231"}