Quick answers
- What is Diazepam used for?
- The FDA-approved label (Valium, Roche Laboratories Inc., December 1, 2025) says: “INDICATIONS Valium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Diazepam have a boxed warning?
- Yes. The FDA label for Valium has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Diazepam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Diazepam been recalled?
- FDA enforcement reports list 7 recalls of products of this medicine; the newest started July 10, 2018 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Diazepam?
- 47 companies list prescription products of Diazepam in the FDA NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc. and A-S Medication Solutions.
What Diazepam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS Valium is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Valium may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. …
— FDA label: Valium, Roche Laboratories Inc., effective December 1, 2025. Read the full label on DailyMed →
The FDA has 86 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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 →
83 of 86 FDA labels for this medicine have a boxed warning.
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| diazepam 10 mg tablet | Generic | $0.0272 per tablet |
| diazepam 10 mg/0.1 mL spray | Brand: Valtoco | $365.36–$365.37 per unit 2 packages, lowest to highest |
| diazepam 10 mg/2 g gel | Generic | $212.51 per unit |
| diazepam 10 mg/2 mL gel | Generic | $212.51 per unit |
| diazepam 2 mg tablet | Generic | $0.0209 per tablet |
| diazepam 20 mg/4 mL gel | Generic | $165.36 per unit |
| diazepam 5 mg tablet | Generic | $0.0259 per tablet |
| diazepam 5 mg/0.1 mL spray | Brand: Valtoco | $365.82 per unit |
| diazepam 5 mg/5 mL solution | Generic | $0.1063 per mL |
| diazepam 5 mg/mL injection, solution | Generic | $3.38 per mL |
| diazepam 5 mg/mL solution | Generic | $1.08 per mL |
| diazepam 5 mg/mL solution, concentrate | Generic | $1.08 per mL |
| diazepam 7.5 mg/0.1 mL spray | Brand: Valtoco | $365.41 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Bryant Ranch Prepack7 products
- Asclemed USA, Inc.6 products
- A-S Medication Solutions5 products
- Remedyrepack Inc.5 products
- Hikma Pharmaceuticals USA Inc.5 products
- NuCare Pharmaceuticals, Inc.5 products
- Chartwell RX, LLC5 products
- PD-Rx Pharmaceuticals, Inc.4 products
- Direct_Rx4 products
- Neurelis, Inc4 products
- Aphena Pharma Solutions - Tennessee, LLC3 products
- Safecor Health LLC3 products
- Navinta LLC3 products
- Mylan Pharmaceuticals Inc.3 products
- Advanced Rx of Tennessee, LLC3 products
- Proficient Rx LP3 products
- Sunrise Pharmaceutical, Inc.3 products
- Mylan Institutional Inc.3 products
- Natco Pharma USA LLC3 products
- Henry Schein, Inc.3 products
- Waylis Therapeutics LLC3 products
- Clinical Solutions Wholesale, LLC3 products
- Oceanside Pharmaceuticals3 products
- Zydus Pharmaceuticals USA Inc.3 products
- Teva Pharmaceuticals USA, Inc.3 products
- Aurobindo Pharma Limited3 products
- Medical Purchasing Solutions, LLC2 products
- Civica, Inc.2 products
- Dr. Reddy's Laboratories Inc.2 products
- Unit Dose Solutions, Inc.2 products
- Roche Laboratories Inc.2 products
- Baxter Healthcare Corporation2 products
- Preferred Pharmaceuticals Inc.2 products
- Hospira, Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Coupler LLC2 products
- Chartwell Governmental & Specialty RX, LLC.1 product
- Meridian Medical Technologies LLC1 product
- Sagent Pharmaceuticals1 product
- Cardinal Health 107, LLC1 product
- Precision Dose, Inc.1 product
- Pharmaceutical Associates, Inc.1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Alembic Pharmaceuticals Limited1 product
- American Health Packaging1 product
- Alembic Pharmaceuticals Inc.1 product
- Fresenius Kabi USA, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA013263 VALIUM | Waylis Therap | November 15, 1963 | 60, latest September 24, 2026 2026: Labeling · 2024: Labeling · 2023: Labeling |
| NDA020124 DIAZEPAM | Us Army | December 5, 1990 | 14, latest January 13, 2023 2023: Labeling · 2021: Labeling · 2016: Labeling |
| NDA020648 DIASTAT, DIASTAT ACUDIAL | Bausch | July 29, 1997 | 14, latest July 10, 2023 2023: Manufacturing (CMC) · 2023: Labeling · 2021: Labeling |
| NDA211635 VALTOCO | Neurelis Inc | January 10, 2020 | 5, latest June 14, 2025 2025: Manufacturing (CMC) · 2025: Efficacy · 2023: Labeling |
Generic approvals (25)
- ANDA070325Mylan · September 4, 1985
- ANDA070311Hikma · December 16, 1985
- ANDA070313Hikma · December 16, 1985
- ANDA070302Chartwell Rx · December 20, 1985
- ANDA070303Chartwell Rx · December 20, 1985
- ANDA070304Chartwell Rx · December 20, 1985
- ANDA070464Nuvo Pharm · February 25, 1986
- ANDA071307Ivax Sub Teva Pharms · December 10, 1986
- ANDA071321Ivax Sub Teva Pharms · December 10, 1986
- ANDA071322Ivax Sub Teva Pharms · December 10, 1986
- ANDA070928Hikma · April 3, 1987
- ANDA071415Hikma · April 3, 1987
- ANDA071583Hospira · October 13, 1987
- ANDA072079Hospira · December 20, 1988
- ANDA204433Chartwell Molecular · April 14, 2014
- ANDA206477Chartwell Molecular · June 24, 2016
- ANDA210363Regcon Holdings · March 18, 2019
- ANDA211998Regcon Holdings · December 26, 2019
- ANDA214745Fresenius Kabi USA · November 10, 2022
- ANDA091076Novel Labs Inc · May 30, 2023
- ANDA217843Aurobindo Pharma Ltd · December 14, 2023
- ANDA218450Alembic · April 25, 2024
- ANDA218422DR Reddys · July 18, 2024
- ANDA217468Navinta LLC · November 14, 2025
- ANDA219882Baxter Hlthcare Corp · July 28, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 10, 2018 · Class III · Terminated · D-1041-2018
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a — Valeant Pharmaceuticals North America LLC
-
June 23, 2016 · Class II · Terminated · D-1359-2016
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32 — Hospira Inc.
-
August 16, 2013 · Class II · Terminated · D-927-2013
Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials.
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12 — Hospira Inc.
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May 16, 2013 · Class II · Terminated · D-501-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 — Hospira Inc.
-
February 26, 2013 · Class II · Terminated · D-313-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 — Hospira Inc.
-
August 28, 2012 · Class II · Terminated · D-309-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12 — Hospira Inc.
-
June 6, 2012 · Class II · Terminated · D-1369-2012
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharma — Meridian Medical Technologies a Pfizer Company
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Valium, Roche Laboratories Inc., effective December 1, 2025; 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 →