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Brand-name prescription medicine

Restoril

Generic name: Temazepam

FDA application holder: Specgx LLC

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

4Strengths and forms
84Same medicine, other names
1981FDA approval
0Recalls (FDA reports)

Quick answers

What is Restoril?
Restoril is a brand name of Temazepam, a prescription medicine. The FDA NDC Directory lists 4 Restoril products in 4 strengths and forms.
Who makes Restoril?
Specgx LLC holds the FDA application for Restoril (NDA018163, approved February 27, 1981).
Is there a generic or store brand of Restoril?
Yes. The FDA NDC Directory lists 84 other products with the same active ingredients, strength and form as a Restoril product, 75 of them generic. Ask your pharmacist whether one is right for you.
Has Restoril been recalled?
No recall linked to Restoril products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Restoril is

Each Restoril product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Temazepam · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
temazepam 15 mg
capsule (oral)		 Restoril 30 products, 19 companies DailyMed
temazepam 22.5 mg
capsule (oral)		 Restoril 10 products, 8 companies DailyMed
temazepam 30 mg
capsule (oral)		 Restoril 32 products, 19 companies DailyMed
temazepam 7.5 mg
capsule (oral)		 Restoril 12 products, 11 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Temazepam →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Restoril products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA018163Specgx LLCFebruary 27, 19814

Companies that list Restoril

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Restoril products.

Recalls

No recall linked to Restoril products (by their NDC code or label) appears in the FDA enforcement reports.

Sources

  1. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  2. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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