xywav

Generic: calcium, magnesium, potassium, and sodium oxybates

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xywav
Generic Name calcium, magnesium, potassium, and sodium oxybates
Labeler jazz pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

calcium oxybate .5 g/mL, magnesium oxybate .5 g/mL, potassium oxybate .5 g/mL, sodium oxybate .5 g/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-150
Product ID 68727-150_6815ce2b-51e5-4d03-92a6-523718ab0d8c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA212690
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2020-11-02

Pharmacologic Class

Classes
central nervous system depressant [epc] central nervous system depression [pe] decreased central nervous system organized electrical activity [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68727150
Hyphenated Format 68727-150

Supplemental Identifiers

RxCUI
2393794 2393795
UNII
8W24SYD6ZI G983HLV265 S8NKF3H3KT 7G33012534

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name xywav (source: ndc)
Generic Name calcium, magnesium, potassium, and sodium oxybates (source: ndc)
Application Number NDA212690 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/mL
source: ndc
Packaging
  • 180 mL in 1 BOTTLE, PLASTIC (68727-150-01)
source: ndc

Packages (1)

68727-150-01 180 mL in 1 BOTTLE, PLASTIC (68727-150-01)

Ingredients (4)

calcium oxybate (.5 g/mL) magnesium oxybate (.5 g/mL) potassium oxybate (.5 g/mL) sodium oxybate (.5 g/mL)

Linked Drug Pages (1)

XYWAV ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6815ce2b-51e5-4d03-92a6-523718ab0d8c", "openfda": {"unii": ["8W24SYD6ZI", "G983HLV265", "S8NKF3H3KT", "7G33012534"], "rxcui": ["2393794", "2393795"], "spl_set_id": ["1e0ae43a-037f-42af-8e23-a0e51d75abe8"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 mL in 1 BOTTLE, PLASTIC (68727-150-01)", "package_ndc": "68727-150-01", "marketing_start_date": "20201102"}], "brand_name": "XYWAV", "product_id": "68727-150_6815ce2b-51e5-4d03-92a6-523718ab0d8c", "dosage_form": "SOLUTION", "pharm_class": ["Central Nervous System Depressant [EPC]", "Central Nervous System Depressant [EPC]", "Central Nervous System Depressant [EPC]", "Central Nervous System Depressant [EPC]", "Central Nervous System Depression [PE]", "Central Nervous System Depression [PE]", "Central Nervous System Depression [PE]", "Central Nervous System Depression [PE]", "Decreased Central Nervous System Organized Electrical Activity [PE]", "Decreased Central Nervous System Organized Electrical Activity [PE]", "Decreased Central Nervous System Organized Electrical Activity [PE]", "Decreased Central Nervous System Organized Electrical Activity [PE]"], "product_ndc": "68727-150", "dea_schedule": "CIII", "generic_name": "calcium, magnesium, potassium, and sodium oxybates", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "XYWAV", "active_ingredients": [{"name": "CALCIUM OXYBATE", "strength": ".5 g/mL"}, {"name": "MAGNESIUM OXYBATE", "strength": ".5 g/mL"}, {"name": "POTASSIUM OXYBATE", "strength": ".5 g/mL"}, {"name": "SODIUM OXYBATE", "strength": ".5 g/mL"}], "application_number": "NDA212690", "marketing_category": "NDA", "marketing_start_date": "20201102", "listing_expiration_date": "20261231"}