sodium oxybate

Generic: sodium oxybate

Labeler: xlcare pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sodium oxybate .5 g/mL

Manufacturer
XLCare Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72865-349
Product ID 72865-349_978891be-92e4-4aa0-9e01-6733b1148bc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210523
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2026-01-01

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 72865349
Hyphenated Format 72865-349

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 ANDA210523 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • .5 g/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72865-349-18) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

72865-349-18 1 BOTTLE in 1 CARTON (72865-349-18) / 180 mL in 1 BOTTLE

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": "978891be-92e4-4aa0-9e01-6733b1148bc3", "openfda": {"unii": ["7G33012534"], "rxcui": ["349482"], "spl_set_id": ["c0fb2620-7247-464d-a37a-8b516ce7d563"], "manufacturer_name": ["XLCare Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72865-349-18)  / 180 mL in 1 BOTTLE", "package_ndc": "72865-349-18", "marketing_start_date": "20260101"}], "brand_name": "sodium oxybate", "product_id": "72865-349_978891be-92e4-4aa0-9e01-6733b1148bc3", "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": "72865-349", "dea_schedule": "CIII", "generic_name": "sodium oxybate", "labeler_name": "XLCare Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sodium oxybate", "active_ingredients": [{"name": "SODIUM OXYBATE", "strength": ".5 g/mL"}], "application_number": "ANDA210523", "marketing_category": "ANDA", "marketing_start_date": "20260101", "listing_expiration_date": "20271231"}