Quick answers
- What is Minivelle?
- Minivelle is a brand name of Estradiol, a prescription medicine. The FDA NDC Directory lists 5 Minivelle products in 5 strengths and forms.
- Who makes Minivelle?
- Noven holds the FDA application for Minivelle (NDA203752, approved October 29, 2012).
- Is there a generic or store brand of Minivelle?
- Yes. The FDA NDC Directory lists 6 other products with the same active ingredients, strength and form as a Minivelle product, 6 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Minivelle?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 5 Minivelle strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Minivelle been recalled?
- FDA enforcement reports list 9 recalls of Minivelle products; the newest started April 16, 2021. A recall usually concerns specific lots, not every product.
What Minivelle is
Each Minivelle 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 · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| estradiol 0.025 mg/d film, extended release (transdermal) | Minivelle | 1 product, 1 company | DailyMed |
| estradiol 0.0375 mg/d film, extended release (transdermal) | Minivelle | 2 products, 2 companies | DailyMed |
| estradiol 0.05 mg/d film, extended release (transdermal) | Minivelle | 1 product, 1 company | DailyMed |
| estradiol 0.075 mg/d film, extended release (transdermal) | Minivelle | 1 product, 1 company | DailyMed |
| estradiol 0.1 mg/d film, extended release (transdermal) | Minivelle | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Estradiol →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA203752 | Noven | October 29, 2012 | 5 |
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 |
|---|---|---|
| estradiol 0.025 mg/d film, extended release | Brand: Minivelle | $11.59 per unit Generic of the same strength and form: $8.01 per unit |
| estradiol 0.0375 mg/d film, extended release | Brand: Minivelle | $11.58 per unit Generic of the same strength and form: $8.26 per unit |
| estradiol 0.05 mg/d film, extended release | Brand: Minivelle | $11.58 per unit Generic of the same strength and form: $8.61 per unit |
| estradiol 0.075 mg/d film, extended release | Brand: Minivelle | $11.57 per unit Generic of the same strength and form: $8.23 per unit |
| estradiol 0.1 mg/d film, extended release | Brand: Minivelle | $11.57 per unit Generic of the same strength and form: $8.73 per unit |
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 Minivelle
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Minivelle products.
- Noven Therapeutics, LLC5 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
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April 16, 2021 · Class II · Terminated · D-0336-2021
Defective Delivery System: Out of specification for release rate testing and shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Minivelle (estradiol transdermal system) Delivers 0.075 mg/day, 8 patches/box, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. by: Noven Therapeutics, LLC Miami, Florida 33186, NDC 68968-6675-8 — Noven Pharmaceuticals Inc
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September 7, 2018 · Class II · Terminated · D-1207-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florid — Noven Pharmaceuticals, Inc.
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September 7, 2018 · Class II · Terminated · D-1210-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 6 — Noven Pharmaceuticals, Inc.
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September 7, 2018 · Class II · Terminated · D-1208-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 3 — Noven Pharmaceuticals, Inc.
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September 7, 2018 · Class II · Terminated · D-1209-2018
Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 6 — Noven Pharmaceuticals, Inc.
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May 4, 2018 · Class II · Terminated · D-0862-2018
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: — Noven Pharmaceuticals, Inc.
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May 4, 2018 · Class II · Terminated · D-0863-2018
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. — Noven Pharmaceuticals, Inc.
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April 27, 2017 · Class III · Terminated · D-0923-2017
Defective Delivery System: Out of specification for peel force from the release liner specification during stability testing at 18M 25C/60%RH.
Minivelle (estradiol Transdermal System) 0.1 mg per day, pack of 8 systems per carton, Rx only, Dist. by: Noven Therapeutics, LLC. Miami, Florida 33186. NDC: 68968-6610-8 — Noven Pharmaceuticals, Inc.
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February 25, 2015 · Class II · Terminated · D-0485-2015
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Minivelle (estradiol transdermal system) 0.05 mg/day, 8-count box, Rx only, Manufactured by Noven Pharmaceuticals, Inc., Miami, Florida 33186, Distributed by Noven Pharmaceuticals, LLC, Miami, Florida 33186, NDC 68968-66 — Noven Pharmaceuticals, Inc.
Sources
- 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 labeling (SPL, 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
- 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.