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Brand-name prescription medicine

Activella

Generic name: Estradiol and norethindrone acetate

FDA application holder: Amneal

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.

Quick answers

What is Activella?
Activella is a brand name of Estradiol and norethindrone acetate, a prescription medicine. The FDA NDC Directory lists 2 Activella products in 2 strengths and forms.
Who makes Activella?
Amneal holds the FDA application for Activella (NDA020907, approved November 18, 1998).
Is there a generic or store brand of Activella?
Yes. The FDA NDC Directory lists 10 other products with the same active ingredients, strength and form as a Activella product, 8 of them generic. Ask your pharmacist whether one is right for you.
Has Activella been recalled?
No recall linked to Activella products (by their NDC code or label) appears in the FDA enforcement reports we use.

What Activella is

Each Activella 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)
Activella 4 products, 3 companies DailyMed
estradiol 1 mg · norethindrone acetate 0.5 mg
tablet, film coated (oral)
Activella 6 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 Activella products (Drugs@FDA)
ApplicationHolderFirst approvedProducts
NDA020907AmnealNovember 18, 19982

Companies that list Activella

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

Recalls

No recall linked to Activella 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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