NDC 68462-711
Estradiol Vaginal Inserts 10 ug tablet, film coated
On the label: Glenmark Pharmaceuticals Inc., USA.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Glenmark Pharmaceuticals Limited | Goa, India | Makes it and tests it | Problems found, fixed voluntarilyJun 30, 2026 · 7 inspections, 1 with FDA action |
Recalls
- Oct 22, 2019 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator.
Lots: Batch numbers: a) 20180514, 20180544, Apr-2020; 20180545, 20180546, 20180588, May-2020; 20190003, Jun-2020; b) 20180515, 20180543, Apr-2020; 20180587, May-2020 - Jun 3, 2019 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.
Lots: Lot#: 20180516, Exp 4/30/2020 - Dec 26, 2018 · Class II · Glenmark Pharmaceuticals Inc., USA
Defective Delivery System: Customer complaints of malfunctioning plunger of the applicator
Lots: Batch numbers: a) 20180393, exp. date 01/31/2020, 20180424, exp. date 02/29/2020, 20180425, exp. date 02/29/2020, 20180427, exp. date 02/29/2020; b) 20180338, exp. date 12/31/2019, 20180386, exp. date 01/31/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Estradiol: every company that makes it
- Form
- tablet, film coated, vaginal
- Strength
- 10 ug
- Approval
- ANDA ANDA210264
- On the market since
- Sep 17, 2018
- Package NDCs
68462-711-7168462-711-88- Official label
- DailyMed (National Library of Medicine), updated Oct 28, 2025
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