Quick answers
- What is Estrogens, conjugated used for?
- The FDA-approved label (Premarin, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., June 4, 2026) says: “PREMARIN is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease • Treatment of …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Estrogens, conjugated have a boxed warning?
- Yes. The FDA label for Premarin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Estrogens, conjugated?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Estrogens, conjugated been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started September 15, 2016 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Estrogens, conjugated?
- 4 companies list prescription products of Estrogens, conjugated in the FDA NDC Directory, including Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., Ingenus Pharmaceuticals, LLC and Prasco Laboratories.
What Estrogens, conjugated is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PREMARIN is a mixture of estrogens indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause • Treatment of Hypoestrogenism due to Hypogonadism, Castration or Primary Ovarian Failure • Treatment of Breast Cancer (for Palliation Only) in Appropriately Selected Women and Men with Metastatic Disease • Treatment of …
— FDA label: Premarin, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective June 4, 2026. Read the full label on DailyMed →
The FDA has 8 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.
This label has a boxed warning. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Cream · Injection, powder, lyophilized, for solution |
|---|---|
| Route | Oral · Vaginal · Intramuscular · Intravenous |
| Prescription products | 19 in the FDA NDC Directory |
| Brand names | Premarin, Premarin Vaginal |
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| estrogens, conjugated 0.0625% cream | Brand: Premarin Vaginal | $15.07 per gram |
| estrogens, conjugated 0.3 mg tablet, film coated | Generic | $5.30 per tablet |
| estrogens, conjugated 0.3 mg tablet, film coated | Brand: Premarin | $6.95 per tablet |
| estrogens, conjugated 0.45 mg tablet, film coated | Generic | $5.35 per tablet |
| estrogens, conjugated 0.45 mg tablet, film coated | Brand: Premarin | $6.95 per tablet |
| estrogens, conjugated 0.625 mg tablet, film coated | Generic | $5.38 per tablet |
| estrogens, conjugated 0.625 mg tablet, film coated | Brand: Premarin | $6.94 per tablet |
| estrogens, conjugated 0.9 mg tablet, film coated | Generic | $5.57 per tablet |
| estrogens, conjugated 0.9 mg tablet, film coated | Brand: Premarin | $6.93 per tablet |
| estrogens, conjugated 1.25 mg tablet, film coated | Generic | $5.47 per tablet |
| estrogens, conjugated 1.25 mg tablet, film coated | Brand: Premarin | $6.95 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.
- Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.7 products
- Ingenus Pharmaceuticals, LLC5 products
- Prasco Laboratories5 products
- A-S Medication Solutions2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA004782 PREMARIN | Wyeth Pharms | May 8, 1942 | 75, latest April 22, 2025 2025: Labeling · 2024: Labeling · 2017: Labeling |
| NDA010402 PREMARIN | Wyeth Pharms | December 18, 1956 | 23, latest February 15, 2024 2024: Labeling · 2017: Labeling · 2012: Labeling |
| NDA020216 PREMARIN | Wyeth Pharms | October 16, 1978 | 39, latest April 22, 2025 2025: Labeling · 2024: Labeling · 2017: Labeling |
Generic approvals (2)
- ANDA214023Novast Labs · October 15, 2025
- ANDA214025Novast Labs · October 15, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
September 15, 2016 · Class III · Terminated · D-1528-2016
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
PREMARIN (conjugated estrogen tablets, USP) 1.25 mg, 1000- count bottle, Rx only, Distributed by: Wyeth Pharmaceuticals Inc. A subsidiary of Pfizer Inc. Philadelphia, PA 19101, NDC 0046-1104-91 — Pfizer Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Premarin, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective June 4, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →