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Brand-name prescription medicine

Lopreeza

Generic name: Estradiol and norethindrone acetate

FDA application holder: Amneal

Strengths and generic versions Official label

Official data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the NDC Directory, Drugs@FDA, the official labels and recall reports; pharmacy costs come from the Centers for Medicare & Medicaid Services (CMS). Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or switch any medicine, including a switch between a brand and a generic.

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

At a glance

2Strengths and forms
8Same medicine, other names
1998FDA approval
0Recalls (FDA reports)

Quick answers

What is Lopreeza?
Lopreeza is a brand name of Estradiol and norethindrone acetate, a prescription medicine. The FDA NDC Directory lists 4 Lopreeza products in 2 strengths and forms.
Who makes Lopreeza?
Amneal holds the FDA application for Lopreeza (NDA020907, approved November 18, 1998).
Is there a generic or store brand of Lopreeza?
Yes. The FDA NDC Directory lists 8 other products with the same active ingredients, strength and form as a Lopreeza product, 6 of them generic. Ask your pharmacist whether one is right for you.
Has Lopreeza been recalled?
No recall linked to Lopreeza products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Lopreeza is

Each Lopreeza product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.

Estradiol and norethindrone acetate · prescription medicine

Strength and formProduct namesSame medicine, other namesLabel
estradiol 0.5 mg · norethindrone acetate 0.1 mg
tablet, film coated (oral)		 Lopreeza 3 products, 3 companies DailyMed
estradiol 1 mg · norethindrone acetate 0.5 mg
tablet, film coated (oral)		 Lopreeza 5 products, 5 companies DailyMed

Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Estradiol and norethindrone acetate →

FDA approval

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
FDA applications of Lopreeza products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA020907AmnealNovember 18, 19984

Companies that list Lopreeza

The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Lopreeza products.

Recalls

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

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 labeling (SPL, 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. NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026

Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.

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