sodium oxybate

Generic: sodium oxybate

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sodium oxybate
Generic Name sodium oxybate
Labeler hikma pharmaceuticals usa inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sodium oxybate .5 g/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0054-9628
Product ID 0054-9628_599719a1-b644-4ece-b0c0-ce8d85378e01
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021196
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-01-03

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 00549628
Hyphenated Format 0054-9628

Supplemental Identifiers

RxCUI
349482
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 sodium oxybate (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 (0054-9628-57)
source: ndc

Packages (1)

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

Ingredients (1)

sodium oxybate (.5 g/mL)

Linked Drug Pages (1)

sodium oxybate ndc-match (0.9)

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"}