Package 0054-9628-57

Brand: sodium oxybate

Generic: sodium oxybate
NDC Package

Package Facts

Identity

Package NDC 0054-9628-57
Digits Only 0054962857
Product NDC 0054-9628
Product ID 0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01
Description

180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)

Marketing

Marketing Status
Marketed Since 2023-01-03
Brand sodium oxybate
Generic sodium oxybate
Sample Package No

Linked Drug Pages (1)

sodium oxybate ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "599719a1-b644-4ece-b0c0-ce8d85378e01", "openfda": {"unii": ["7G33012534"], "rxcui": ["349482"], "spl_set_id": ["bcef2c95-35e9-464d-9025-652acff769e7"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)", "package_ndc": "0054-9628-57", "marketing_start_date": "20230103"}], "brand_name": "sodium oxybate", "product_id": "0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Depressant [EPC]", "Central Nervous System Depression [PE]", "Decreased Central Nervous System Organized Electrical Activity [PE]"], "product_ndc": "0054-9628", "dea_schedule": "CIII", "generic_name": "sodium oxybate", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sodium oxybate", "active_ingredients": [{"name": "SODIUM OXYBATE", "strength": ".5 g/mL"}], "application_number": "NDA021196", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20230103", "listing_expiration_date": "20261231"}