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Prescription medicine

Ulipristal acetate

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 Ulipristal acetate used for?
The FDA-approved label (Ella, PMI Branded Pharmaceuticals, Inc., July 20, 2026) says: “Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure […]. Ella is not intended for routine use as a contraceptive. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Ulipristal acetate have a boxed warning?
No. None of the 2 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Ulipristal acetate?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Ulipristal acetate been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Ulipristal acetate?
2 companies list prescription products of Ulipristal acetate in the FDA NDC Directory, including PMI Branded Pharmaceuticals, Inc. and A-S Medication Solutions.

What Ulipristal acetate is used for

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

Ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure […]. Ella is not intended for routine use as a contraceptive. …

— FDA label: Ella, PMI Branded Pharmaceuticals, Inc., effective July 20, 2026. Read the full label on DailyMed →

The FDA has 2 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.

The label quoted above has no boxed warning.

0 of 2 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsTablet
RouteOral
Prescription products2 in the FDA NDC Directory
Brand namesElla

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 Ulipristal acetate, by strength and form
Strength and formGeneric or brandPharmacies pay
ulipristal acetate 30 mg
tablet
Brand: Ella $37.08 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
NDA022474
ELLA
Lab Hra PharmaAugust 13, 2010 8, latest June 24, 2021
2021: Efficacy · 2018: Labeling · 2015: 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

RxCUI (RxNorm)1005924, 1005928
SPL set ID of the quoted label2bf93d23-cddd-4613-9066-5b5fa090404b
FDA labels (SPL)2
FDA applicationsNDA022474
Active ingredients (FDA)ULIPRISTAL ACETATE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Ella, PMI Branded Pharmaceuticals, Inc., effective July 20, 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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