NDC 12634-789
Metformin Hydrochloride 1000 mg tablet, film coated
On the label: Apotheca, Inc.. It's repackaged: Apotheca, Inc. rebottles it from Ascend Laboratories, LLC's NDC 67877-221.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Alkem Laboratories Limited | Amaliya Daman, India | Makes it | No problems foundAug 30, 2019 · 6 inspections |
| Alkem Laboratories Limited | Baddi Solan, India | Makes it | Problems found, fixed voluntarilyMar 27, 2024 · 9 inspections |
Repackaging site
- Apotheca Inc., Phoenix, AZ, United States · repackages it and relabels it
Recalls
- Nov 2, 2016 · Class II · Ascend Laboratories LLC
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Lots: Lot 6121056, exp 5/2019
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Metformin: every company that makes it
- Form
- tablet, film coated
- Strength
- 1000 mg
- Approval
- ANDA ANDA091184
- On the market since
- Jan 31, 2011
- Package NDCs
12634-789-0012634-789-0112634-789-0912634-789-1212634-789-1812634-789-4012634-789-4212634-789-4512634-789-5012634-789-5212634-789-5412634-789-57- Official label
- DailyMed (National Library of Medicine), updated Jan 17, 2017
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