TheraRadar
Data updated: May 26, 2026

NEMBUTAL SODIUM (pentobarbital sodium)

CNS Approved 1973-09-19

NEMBUTAL SODIUM is indicated for the treatment of Insomnia; Convulsions; Status Epilepticus; Cholera; Eclampsia; Meningitis; Tetanus.

Source: FDA Label • RISING
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-09-19
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, CAPSULE

Companies

RISING EPIC PHARMA LLC
Active Ingredient: PENTOBARBITAL SODIUM

NEMBUTAL SODIUM Approval History

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Original
New Indication
New Form
Label Update
23 FDA actions from 1973 to 2019
Feb 2019 SUPPL
Label · Labeling
Apr 2017 SUPPL
Label · Labeling
May 2007 SUPPL
Label · Labeling

What NEMBUTAL SODIUM Treats

7 indications

NEMBUTAL SODIUM is approved for 7 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Insomnia
  • Convulsions
  • Status Epilepticus
  • Cholera
  • Eclampsia
  • Meningitis
  • Tetanus
Source: FDA Label

NEMBUTAL SODIUM Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

SUBVENITE
OWP PHARMS
2025 5 indic.
PERAMPANEL
MSN
2025 3 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to NEMBUTAL SODIUM

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AMBIEN
ZOLPIDEM TARTRATE
1 shared
COSETTE
Shared indications:
Insomnia
AMBIEN CR
ZOLPIDEM TARTRATE
1 shared
COSETTE
Shared indications:
Insomnia
ANCOBON
FLUCYTOSINE
1 shared
BAUSCH
Shared indications:
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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

NEMBUTAL SODIUM FDA Label Details

Indications & Usage

NEMBUTAL SODIUM is indicated for the treatment of Insomnia; Convulsions; Status Epilepticus; Cholera; Eclampsia; Meningitis; Tetanus.

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Data Sources

FDA Approval: ANDA083246 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.