Quick answers
- What is Estradiol Vaginal Inserts?
- Estradiol Vaginal Inserts is a brand name of Estradiol, a prescription medicine. The FDA NDC Directory lists 3 Estradiol Vaginal Inserts products in 2 strengths and forms.
- Who makes Estradiol Vaginal Inserts?
- Aurobindo Pharma holds the FDA application for Estradiol Vaginal Inserts (ANDA210264, approved September 14, 2018). 2 other companies (repackagers or distributors) also list Estradiol Vaginal Inserts products.
- Is there a generic or store brand of Estradiol Vaginal Inserts?
- Other products of Estradiol are listed with the FDA, but none in exactly the same strength and form as a Estradiol Vaginal Inserts product.
- What do pharmacies pay for Estradiol Vaginal Inserts?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 2 Estradiol Vaginal Inserts 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 Estradiol Vaginal Inserts been recalled?
- FDA enforcement reports list 3 recalls of Estradiol Vaginal Inserts products; the newest started October 22, 2019. A recall usually concerns specific lots, not every product.
What Estradiol Vaginal Inserts is
Each Estradiol Vaginal Inserts 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 10 ug tablet, film coated (vaginal) | Estradiol Vaginal Inserts | None listed | DailyMed |
| estradiol hemihydrate 10 ug tablet, film coated (vaginal) | Estradiol Vaginal Inserts | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Estradiol →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA210264 | Glenmark Pharms Ltd | September 14, 2018 | 1 |
| ANDA216550 | Aurobindo Pharma | August 2, 2024 | 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 |
|---|---|---|
| estradiol 10 ug tablet, film coated | Generic: Estradiol Vaginal Inserts | $5.50 per tablet Generic of the same strength and form: $5.50 per tablet |
| estradiol hemihydrate 10 ug tablet, film coated | Generic: Estradiol Vaginal Inserts | $5.50 per tablet Generic of the same strength and form: $5.50 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 Estradiol Vaginal Inserts
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Estradiol Vaginal Inserts products.
- NorthStar Rx LLC1 product
- Aurobindo Pharma Limited1 product
- Glenmark Pharmaceuticals Inc., USA1 product
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.
-
October 22, 2019 · Class II · Terminated · D-0156-2020
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 6846 — Glenmark Pharmaceuticals Inc., USA
-
June 3, 2019 · Class II · Terminated · D-1340-2019
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Estradiol Vaginal Inserts USP 10 mcg, packaged in box of 8 Vaginal Inserts (with disposable applicators), Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa 403 513 India, Manufactured for: Glenm — Glenmark Pharmaceuticals Inc., USA
-
December 26, 2018 · Class II · Terminated · D-0350-2019
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Estradiol Vaginal Inserts, USP, 10 mcg, Rx only, packaged in a) 8 count (NDC 68462-711-71) and b) 18 count (NDC 68462-711-88) cartons, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale, Goa India, Manufactured for — Glenmark Pharmaceuticals Inc., USA
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.