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Prescription medicine

Apremilast

Drug class: Phosphodiesterase 4 Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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

What is Apremilast used for?
The FDA-approved label (Otezla, Amgen, Inc, September 2, 2026) says: “OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis Plaque psoriasis who are candidates for phototherapy or systemic therapy Oral ulcers associated with Behçet's Disease Pediatric patients 6 years of age and older with …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Apremilast have a boxed warning?
No. None of the 1 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Apremilast?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Apremilast been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Apremilast?
1 company lists prescription products of Apremilast in the FDA NDC Directory, including Amgen, Inc.

What Apremilast is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis Plaque psoriasis who are candidates for phototherapy or systemic therapy Oral ulcers associated with Behçet's Disease Pediatric patients 6 years of age and older with …

— FDA label: Otezla, Amgen, Inc, effective September 2, 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.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

Forms and how it is given

Dosage formsTablet, film coated
RouteOral
Prescription products3 in the FDA NDC Directory
Brand namesOtezla

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 Apremilast, by strength and form
Strength and formGeneric or brandPharmacies pay
apremilast 20 mg
tablet, film coated
Brand: Otezla $89.95 per tablet
apremilast 30 mg
tablet, film coated
Brand: Otezla $90.59 per tablet
apremilast 75 mg
tablet, film coated
Brand: Otezla $181.20 per tablet

NADAC list of November 4, 2026; these prices took effect between January 7, 2026 and 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
NDA205437
OTEZLA
Amgen IncMarch 21, 2014 13, latest December 23, 2025
2025: Labeling · 2025: Efficacy · 2024: Efficacy
NDA210745
OTEZLA, OTEZLA XR
Amgen IncAugust 29, 2025 —

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

RxCUI (RxNorm)1492732, 1492738, 1492740, 1492742, 1492744, 1492746, 1492747, 1492748, 1605454, 1605455 … (+8)
SPL set ID of the quoted labelf6b1f516-4972-4d82-bced-113e47b41cc5
FDA labels (SPL)1
FDA applicationsNDA205437, NDA210745
Active ingredients (FDA)APREMILAST

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Otezla, Amgen, Inc, effective September 2, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. 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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