sodium oxybate

Generic: sodium oxybate

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

Drug Facts

Product Profile

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

sodium oxybate .5 g/mL

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-891
Product ID 31722-891_cd5e0e58-4136-450e-b3bc-c63ffcfc1d94
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 31722891
Hyphenated Format 31722-891

Supplemental Identifiers

RxCUI
349482
UPC
0331722891189
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 (31722-891-18) / 180 mL in 1 BOTTLE
source: ndc

Packages (1)

31722-891-18 1 BOTTLE in 1 CARTON (31722-891-18) / 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": "cd5e0e58-4136-450e-b3bc-c63ffcfc1d94", "openfda": {"upc": ["0331722891189"], "unii": ["7G33012534"], "rxcui": ["349482"], "spl_set_id": ["5dcf9a5c-312b-420b-82f3-42177d8f9ee4"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-891-18)  / 180 mL in 1 BOTTLE", "package_ndc": "31722-891-18", "marketing_start_date": "20260101"}], "brand_name": "sodium oxybate", "product_id": "31722-891_cd5e0e58-4136-450e-b3bc-c63ffcfc1d94", "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": "31722-891", "dea_schedule": "CIII", "generic_name": "sodium oxybate", "labeler_name": "Camber 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"}