Quick answers
- What is Serdexmethylphenidate and dexmethylphenidate used for?
- The FDA-approved label (Azstarys, Commave Sub, LLC, May 11, 2026) says: “AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Serdexmethylphenidate and dexmethylphenidate have a boxed warning?
- Yes. The FDA label for Azstarys has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Serdexmethylphenidate and dexmethylphenidate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Serdexmethylphenidate and dexmethylphenidate been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Serdexmethylphenidate and dexmethylphenidate?
- 1 company lists prescription products of Serdexmethylphenidate and dexmethylphenidate in the FDA NDC Directory, including Commave Sub, LLC.
What Serdexmethylphenidate and dexmethylphenidate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older. Limitations of Use The use of AZSTARYS is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage […]. …
— FDA label: Azstarys, Commave Sub, LLC, effective May 11, 2026. 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 | 3 in the FDA NDC Directory |
| Brand names | Azstarys |
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 |
|---|---|---|
| dexmethylphenidate hydrochloride 10.4 mg · serdexmethylphenidate chloride 52.3 mg capsule | Brand: Azstarys | $14.41 per capsule |
| dexmethylphenidate hydrochloride 5.2 mg · serdexmethylphenidate chloride 26.1 mg capsule | Brand: Azstarys | $14.40 per capsule |
| dexmethylphenidate hydrochloride 7.8 mg · serdexmethylphenidate chloride 39.2 mg capsule | Brand: Azstarys | $14.41 per capsule |
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.
- Commave Sub, LLC3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA212994 AZSTARYS | Commave Sub | March 2, 2021 | 3, latest September 23, 2025 2025: Labeling · 2023: Labeling · 2023: Labeling |
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azstarys, Commave Sub, LLC, effective May 11, 2026; 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 →