NDC 76420-021
Estradiol 0.5 mg tablet
On the label: Asclemed USA, Inc.. It's repackaged: Asclemed USA, Inc. rebottles it from Epic Pharma, LLC's NDC 42806-087.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Granulation Technology, Inc. | Fairfield, NJ, United States | Makes it | Not inspected on record |
Repackaging site
- Asclemed USA Inc. dba Enovachem, Torrance, CA, United States · repackages it and relabels it
Recalls
- Sep 26, 2019 · Class II · Epic Pharma, LLC
Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets.
Lots: Lot #: 19094A, Exp. 2021
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, oral
- Strength
- 0.5 mg
- Approval
- ANDA ANDA040275
- On the market since
- Apr 10, 2017
- Package NDCs
76420-021-3076420-021-90- Official label
- DailyMed (National Library of Medicine), updated Feb 13, 2025
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