Package 68727-100-01

Brand: xyrem

Generic: sodium oxybate
NDC Package

Package Facts

Identity

Package NDC 68727-100-01
Digits Only 6872710001
Product NDC 68727-100
Description

180 mL in 1 BOTTLE, PLASTIC (68727-100-01)

Marketing

Marketing Status
Marketed Since 2002-07-17
Brand xyrem
Generic sodium oxybate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3839d447-e97d-496d-8e9d-aaef53f1484f", "openfda": {"unii": ["7G33012534"], "rxcui": ["349482", "352257"], "spl_set_id": ["926eb076-a4a8-45e4-91ef-411f0aa4f3ca"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 mL in 1 BOTTLE, PLASTIC (68727-100-01)", "package_ndc": "68727-100-01", "marketing_start_date": "20020717"}], "brand_name": "Xyrem", "product_id": "68727-100_3839d447-e97d-496d-8e9d-aaef53f1484f", "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": "68727-100", "dea_schedule": "CIII", "generic_name": "sodium oxybate", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xyrem", "active_ingredients": [{"name": "SODIUM OXYBATE", "strength": ".5 g/mL"}], "application_number": "NDA021196", "marketing_category": "NDA", "marketing_start_date": "20020717", "listing_expiration_date": "20261231"}