Sodium Oxybate
Active substance: sodium oxybate
SOLUTION · SODIUM OXYBATE 500 mg/mL
United StatesActive
Marketing holder: Amneal Pharmaceuticals LLC
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- SODIUM OXYBATE · 500 mg/mL
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United StatescontrolledSchedule: CIII
Source: openFDA NDC · record 01a1208e-1a11-7f92-acd1-70920ceb6891,01a12090-d18d-7ab4-83ef-8115f25f61f9,01a12091-6ce5-7279-84ac-348d457f6409,01a12095-7387-795b-9db2-e60e2d333cbc,01a12095-738b-72fc-9d80-e8f73d640896;count=10 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 65162-065
- Registration status
- Active
- Dispensing
- Prescription only
- Control marker
- CIII
- Route
- ORAL
Sources
- product · openFDA NDC · 65162-065 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 65162-065 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 65162-065 · Verified 2026-10-09 · open in source