NDC 43353-688
Premarin 0.625 mg tablet, film coated
On the label: Aphena Pharma Solutions - Tennessee, Inc.. It's repackaged: Aphena Pharma Solutions - Tennessee, Inc. rebottles it from Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.'s NDC 0046-1102.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Pfizer Canada ULC | Brandon, Canada | Makes the active ingredient and tests it | No problems foundAug 3, 2023 · 4 inspections |
| Pfizer Ireland Pharmaceuticals Unlimited Company | Newbridge, Ireland | Makes it, makes the active ingredient, tests it and packages it | Problems found, fixed voluntarilySep 23, 2022 · 8 inspections |
| Pfizer Italia S.r.l. | Ascoli Piceno, Italy | Packages it and labels it | Problems found, fixed voluntarilyMar 14, 2025 · 5 inspections |
Repackaging site
- Aphena Pharma Solutions - Tennessee, LLC, Cookeville, TN, United States · repackages it
Recalls
- Sep 15, 2016 · Class III · Pfizer Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Lots: Lot # M35953S; Exp. 11/17 (labeled).
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Estrogens, Conjugated: every company that makes it
- Form
- tablet, film coated
- Strength
- 0.625 mg
- Approval
- NDA NDA004782
- On the market since
- Jan 1, 2006
- Package NDCs
43353-688-60- Official label
- DailyMed (National Library of Medicine), updated Jul 18, 2012
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