Package 68382-396-01

Brand: sodium phenylacetate and sodium benzoate

Generic: sodium phenylacetate and sodium benzoate
NDC Package

Package 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
Marketed Since 2021-02-08
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"}