Quick answers
- What is Tetrabenazine used for?
- The FDA-approved label (Xenazine, Lundbeck Pharmaceuticals LLC, November 1, 2019) says: “XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tetrabenazine have a boxed warning?
- Yes. The FDA label for Xenazine has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tetrabenazine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tetrabenazine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tetrabenazine?
- 12 companies list prescription products of Tetrabenazine in the FDA NDC Directory, including Ajanta Pharma USA Inc., Camber Pharmaceuticals, Inc. and Sun Pharmaceutical Industries, Inc..
What Tetrabenazine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.
— FDA label: Xenazine, Lundbeck Pharmaceuticals LLC, effective November 1, 2019. Read the full label on DailyMed →
The FDA has 11 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 →
11 of 11 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, coated |
|---|---|
| Route | Oral |
| Prescription products | 24 in the FDA NDC Directory |
| Brand names | Xenazine |
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 |
|---|---|---|
| tetrabenazine 12.5 mg tablet | Generic | $0.6740 per tablet |
| tetrabenazine 12.5 mg tablet, coated | Generic | $0.6740 per tablet |
| tetrabenazine 25 mg tablet | Generic | $1.30 per tablet |
| tetrabenazine 25 mg tablet, coated | Generic | $1.30 per tablet |
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.
- Ajanta Pharma USA Inc.2 products
- Camber Pharmaceuticals, Inc.2 products
- Sun Pharmaceutical Industries, Inc.2 products
- Precision Dose, Inc.2 products
- Oceanside Pharmaceuticals2 products
- Slate Run Pharmaceuticals, LLC2 products
- Golden State Medical Supply, Inc.2 products
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 products
- Apotex Corp.2 products
- Bionpharma Inc.2 products
- Dr.Reddys Laboratories Inc2 products
- Lundbeck Pharmaceuticals LLC2 products
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 |
|---|---|---|---|
| NDA021894 XENAZINE | Bausch | August 15, 2008 | 9, latest September 13, 2017 2017: Labeling · 2015: REMS · 2015: Labeling |
Generic approvals (8)
- ANDA206129Sun Pharm · August 17, 2015
- ANDA204574Hetero Labs Ltd V · February 3, 2016
- ANDA207682Mylan · January 31, 2017
- ANDA208826Bionpharma · December 18, 2017
- ANDA209284DR Reddys · January 8, 2018
- ANDA213316Piramal · January 22, 2020
- ANDA206093Apotex · March 17, 2020
- ANDA213621Ajanta Pharma Ltd · December 4, 2020
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 199592, 805462, 805464, 805466 |
|---|---|
| SPL set ID of the quoted label | ac768bab-8afa-4446-bc7f-caeeffec0cda |
| FDA labels (SPL) | 11 |
| FDA applications | NDA021894, 8 ANDA |
| Active ingredients (FDA) | TETRABENAZINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xenazine, Lundbeck Pharmaceuticals LLC, effective November 1, 2019; 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 →