sodium oxybate

Generic: sodium oxybate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sodium oxybate
Generic Name sodium oxybate
Labeler amneal pharmaceuticals llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

sodium oxybate 500 mg/mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-065
Product ID 65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203631
DEA Schedule ciii
Listing Expiration 2027-12-31
Marketing Start 2025-09-12

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 65162065
Hyphenated Format 65162-065

Supplemental Identifiers

RxCUI
349482
UPC
0365162065879
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 ANDA203631 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 500 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

65162-065-87 1 BOTTLE in 1 CARTON (65162-065-87) / 180 mL in 1 BOTTLE

Ingredients (1)

sodium oxybate (500 mg/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": "fb0e7d54-bf58-46d7-8561-9a270771f0d2", "openfda": {"upc": ["0365162065879"], "unii": ["7G33012534"], "rxcui": ["349482"], "spl_set_id": ["5a9e9045-f04d-46eb-8396-2495c6090a31"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65162-065-87)  / 180 mL in 1 BOTTLE", "package_ndc": "65162-065-87", "marketing_start_date": "20250912"}], "brand_name": "Sodium Oxybate", "product_id": "65162-065_fb0e7d54-bf58-46d7-8561-9a270771f0d2", "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": "65162-065", "dea_schedule": "CIII", "generic_name": "Sodium Oxybate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sodium Oxybate", "active_ingredients": [{"name": "SODIUM OXYBATE", "strength": "500 mg/mL"}], "application_number": "ANDA203631", "marketing_category": "ANDA", "marketing_start_date": "20250912", "listing_expiration_date": "20271231"}