Quick answers
- What is Fyavolv?
- Fyavolv is a brand name of Norethindrone acetate and ethinyl estradiol, a prescription medicine. The FDA NDC Directory lists 2 Fyavolv products in 2 strengths and forms.
- Who makes Fyavolv?
- Lupin holds the FDA application for Fyavolv (ANDA204213, approved December 10, 2015).
- Is there a generic or store brand of Fyavolv?
- Other products of Norethindrone acetate and ethinyl estradiol are listed with the FDA, but none in exactly the same strength and form as a Fyavolv product.
- What do pharmacies pay for Fyavolv?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Fyavolv 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 Fyavolv been recalled?
- No recall linked to Fyavolv products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Fyavolv is
Each Fyavolv 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.
Norethindrone acetate and ethinyl estradiol · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| ethinyl estradiol 0.0025 mg · norethindrone acetate 0.5 mg tablet, film coated (oral) | Fyavolv | None listed | DailyMed |
| ethinyl estradiol 0.005 mg · norethindrone acetate 1 mg tablet, film coated (oral) | Fyavolv | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Norethindrone acetate and ethinyl estradiol →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA204213 | Lupin | December 10, 2015 | 2 |
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 |
|---|---|---|
| ethinyl estradiol 0.0025 mg · norethindrone acetate 0.5 mg tablet, film coated | Generic: Fyavolv | $0.9351 per tablet Generic of the same strength and form: $0.9351 per tablet |
| ethinyl estradiol 0.005 mg · norethindrone acetate 1 mg tablet, film coated | Generic: Fyavolv | $0.6665 per tablet Generic of the same strength and form: $0.6665 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 Fyavolv
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Fyavolv products.
- Lupin Pharmaceuticals, Inc.2 products
Recalls
No recall linked to Fyavolv products (by their NDC code or label) appears in the FDA enforcement reports.
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.