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Prescription medicine

Deutetrabenazine

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

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

Quick answers

Is there a shortage of Deutetrabenazine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Deutetrabenazine been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Deutetrabenazine?
1 company lists prescription products of Deutetrabenazine in the FDA NDC Directory, including Teva Neuroscience, Inc..

What Deutetrabenazine is used for

We did not find an “Indications and Usage” section in the FDA labels for this medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Forms and how it is given

Dosage formsTablet, film coated, extended release · Tablet, coated
RouteOral
Prescription products11 in the FDA NDC Directory
Brand namesAustedo XR, Austedo

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.

NADAC per unit for Deutetrabenazine, by strength and form
Strength and formGeneric or brandPharmacies pay
deutetrabenazine 12 mg
tablet, coated
Brand: Austedo $125.00 per tablet
deutetrabenazine 12 mg
tablet, film coated, extended release
Brand: Austedo XR $166.94 per tablet
deutetrabenazine 18 mg
tablet, film coated, extended release
Brand: Austedo XR $251.16 per tablet
deutetrabenazine 24 mg
tablet, film coated, extended release
Brand: Austedo XR $250.32 per tablet
deutetrabenazine 30 mg
tablet, film coated, extended release
Brand: Austedo XR $332.41 per tablet
deutetrabenazine 36 mg
tablet, film coated, extended release
Brand: Austedo XR $416.58 per tablet
deutetrabenazine 42 mg
tablet, film coated, extended release
Brand: Austedo XR $498.72 per tablet
deutetrabenazine 48 mg
tablet, film coated, extended release
Brand: Austedo XR $502.55 per tablet
deutetrabenazine 6 mg
tablet, coated
Brand: Austedo $83.27 per tablet
deutetrabenazine 6 mg
tablet, film coated, extended release
Brand: Austedo XR $83.14 per tablet
deutetrabenazine 9 mg
tablet, coated
Brand: Austedo $93.83 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.

FDA approval history

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA208082
AUSTEDO
Teva Branded PharmApril 3, 2017 10, latest February 28, 2025
2025: Labeling · 2024: Labeling · 2024: Labeling
NDA216354
AUSTEDO XR
TevaFebruary 17, 2023 3, latest February 28, 2025
2025: Labeling · 2024: Manufacturing (CMC) · 2024: Manufacturing (CMC)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

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

Official identifiers

FDA labels (SPL)0
FDA applicationsNDA208082, NDA216354
Active ingredients (FDA)DEUTETRABENAZINE

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 recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  4. 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 →

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