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Prescription medicine

Drospirenone and estradiol

Drug class: Estrogen, Progestin

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 Drospirenone and estradiol used for?
The FDA-approved label (Angeliq, Bayer HealthCare Pharmaceuticals Inc., March 2, 2026) says: “Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Angeliq is a combination of an estrogen and progestin indicated in a woman with a uterus for the treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Drospirenone and estradiol have a boxed warning?
Yes. The FDA label for Angeliq has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Drospirenone and estradiol?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Drospirenone and estradiol been recalled?
No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
Who makes Drospirenone and estradiol?
1 company lists prescription products of Drospirenone and estradiol in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc..

What Drospirenone and estradiol is used for

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

Use estrogen, alone or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary. Angeliq is a combination of an estrogen and progestin indicated in a woman with a uterus for the treatment of …

— FDA label: Angeliq, Bayer HealthCare Pharmaceuticals Inc., effective March 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.

This label has a boxed warning. Read it on the full label →

Forms and how it is given

Dosage formsTablet, film coated
RouteOral
Prescription products2 in the FDA NDC Directory
Brand namesAngeliq

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 Drospirenone and estradiol, by strength and form
Strength and formGeneric or brandPharmacies pay
drospirenone 0.25 mg · estradiol 0.5 mg
tablet, film coated
Brand: Angeliq $6.36 per tablet
drospirenone 0.5 mg · estradiol 1 mg
tablet, film coated
Brand: Angeliq $6.36 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
NDA021355
ANGELIQ
Bayer HlthcareSeptember 28, 2005 8, latest February 15, 2024
2024: Labeling · 2023: Labeling · 2023: Labeling

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)1483549, 1483550, 1483551, 1483552, 1483553, 1483554
SPL set ID of the quoted label761834c2-6b61-4583-84c2-f1ca4a97c4f2
FDA labels (SPL)1
FDA applicationsNDA021355
Active ingredients (FDA)DROSPIRENONE / ESTRADIOL

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Angeliq, Bayer HealthCare Pharmaceuticals Inc., effective March 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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