Quick answers
- What is Flurazepam hydrochloride used for?
- The FDA-approved label (Flurazepam Hydrochloride, Chartwell RX, LLC, October 28, 2024) says: “Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings […]. Since insomnia is often transient and intermittent, short-term use is usually sufficient. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Flurazepam hydrochloride have a boxed warning?
- Yes. The FDA label for Flurazepam Hydrochloride has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Flurazepam hydrochloride?
- The FDA drug shortage list shows “Current shortage” for a product of this medicine (updated September 15, 2026). Ask your pharmacist about alternatives.
- Has Flurazepam hydrochloride been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Flurazepam hydrochloride?
- 1 company lists prescription products of Flurazepam hydrochloride in the FDA NDC Directory, including Chartwell RX, LLC.
What Flurazepam hydrochloride is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Flurazepam hydrochloride capsules are indicated for the treatment of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings […]. Since insomnia is often transient and intermittent, short-term use is usually sufficient. …
— FDA label: Flurazepam Hydrochloride, Chartwell RX, LLC, effective October 28, 2024. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Capsule |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Chartwell RX, LLC2 products
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA072368Chartwell Rx · March 30, 1989
- ANDA072369Chartwell Rx · March 30, 1989
Shortage status
Current shortage · updated September 15, 2026 · first posted August 3, 2022
| Product | Flurazepam Hydrochloride, Capsule, 15 mg (NDC 62135-736-30) |
|---|---|
| Availability | Available |
| Company | Chartwell Molecular Holdings LLC |
Ask your pharmacist whether your product is affected and what the options are.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1298088, 1298091 |
|---|---|
| SPL set ID of the quoted label | 8f476891-1346-4e8c-ac1b-f8cbdc64f5a1 |
| FDA labels (SPL) | 1 |
| FDA applications | 2 ANDA |
| Active ingredients (FDA) | FLURAZEPAM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Flurazepam Hydrochloride, Chartwell RX, LLC, effective October 28, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →