TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

NEMBUTAL SODIUM

PENTOBARBITAL SODIUM
Approved 1973-09-19
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

Loading approval history...

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

Drugs Similar to NEMBUTAL SODIUM

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:
Meningitis
ARIKAYCE KIT
AMIKACIN SULFATE
1 shared
INSMED INC
Shared indications:
Meningitis
ATIVAN
LORAZEPAM
1 shared
BAUSCH
Shared indications:
Status Epilepticus
BELSOMRA
SUVOREXANT
1 shared
Merck
Shared indications:
Insomnia
CEFUROXIME
CEFUROXIME
1 shared
Hikma
Shared indications:
Meningitis
DAYVIGO
LEMBOREXANT
1 shared
EISAI INC
Shared indications:
Insomnia
DOXEPIN HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE
1 shared
Teva
Shared indications:
Insomnia
EDLUAR
ZOLPIDEM TARTRATE
1 shared
Viatris
Shared indications:
Insomnia
ERAXIS
ANIDULAFUNGIN
1 shared
Pfizer
Shared indications:
Meningitis
ESTAZOLAM
ESTAZOLAM
1 shared
NOVITIUM PHARMA
Shared indications:
Insomnia
ESZOPICLONE
ESZOPICLONE
1 shared
Sun Pharma
Shared indications:
Insomnia
FLUCYTOSINE
FLUCYTOSINE
1 shared
SIGMAPHARM LABS LLC
Shared indications:
Meningitis
HALCION
TRIAZOLAM
1 shared
Pfizer
Shared indications:
Insomnia
LUNESTA
ESZOPICLONE
1 shared
WAYLIS THERAP
Shared indications:
Insomnia
MAGNESIUM SULFATE
MAGNESIUM SULFATE
1 shared
ASPIRO
Shared indications:
Eclampsia
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
MAGNESIUM SULFATE
1 shared
Baxter
Shared indications:
Eclampsia
MAGNESIUM SULFATE IN PLASTIC CONTAINER
MAGNESIUM SULFATE
1 shared
GLAND
Shared indications:
Eclampsia
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
PENICILLIN G POTASSIUM
1 shared
Baxter
Shared indications:
Meningitis
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

Loading...
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

Pro

Indications & Usage

Parenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section). Preanesthetics. Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.

Want competitive intelligence?

See who's developing similar drugs and track their progress

View Pipeline Dashboard

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.