What is NEMBUTAL used for?

NEMBUTAL is an FDA-approved medication. See full prescribing information for approved uses.

Is NEMBUTAL FDA approved?

Yes, NEMBUTAL is FDA approved (first approved 1975-01-08) and manufactured by SCIEGEN PHARMS.

NEMBUTAL is manufactured by SCIEGEN PHARMS.

Data updated: Mar 10, 2026

NEMBUTAL

PENTOBARBITAL

Approved 1975-01-08

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Indications

Phase 3 Trials

Years on Market

Details

Status: Discontinued
First Approved: 1975-01-08
Routes: ORAL, RECTAL
Dosage Forms: ELIXIR, SUPPOSITORY

Companies

SCIEGEN PHARMS

Active Ingredient: PENTOBARBITAL

NEMBUTAL Approval History

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What NEMBUTAL Treats

2 FDA approvals

Originally approved for its first indication in 1975 . Covers 2 distinct patient populations.

Other (2)

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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 FDA Label Details

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Data Sources

FDA Approval: ANDA083244 → Trials: ClinicalTrials.gov →

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