xyrem

Generic: sodium oxybate

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

Drug Facts

Product Profile

Brand Name xyrem
Generic Name sodium oxybate
Labeler jazz pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sodium oxybate .5 g/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68727-100
Product ID 68727-100_3839d447-e97d-496d-8e9d-aaef53f1484f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021196
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2002-07-17

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 68727100
Hyphenated Format 68727-100

Supplemental Identifiers

RxCUI
349482 352257
UNII
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 xyrem (source: ndc)
Generic Name sodium oxybate (source: ndc)
Application Number NDA021196 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/mL
source: ndc
Packaging
  • 180 mL in 1 BOTTLE, PLASTIC (68727-100-01)
source: ndc

Packages (1)

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

Ingredients (1)

sodium oxybate (.5 g/mL)

Linked Drug Pages (1)

Xyrem ndc-match (0.9)

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"}