NDC 65162-178 – Metformin Hydrochloride
Metformin Hydrochloride 500 mg/1 · Tablet, Extended Release · Oral
Product NDC65162-178
Product details
- Brand name
- Metformin Hydrochloride
- Generic name
- Metformin Hydrochloride
- Labeler
- Amneal Pharmaceuticals LLC
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA078596
- Marketed since
- December 2, 2009
- Listing expires
- December 31, 2026
- Pharmacologic class
- Biguanide
Active ingredients
- Metformin Hydrochloride 500 mg/1
Uses, dosage, side effects and warnings for Metformin hydrochloride →
Package NDC codes (6)
| Package NDC | Description | Since |
|---|---|---|
| 65162-178-03 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-03) | Dec 2, 2009 |
| 65162-178-09 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-09) | Dec 2, 2009 |
| 65162-178-10 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-10) | Dec 2, 2009 |
| 65162-178-11 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-11) | Dec 2, 2009 |
| 65162-178-50 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (65162-178-50) | Dec 2, 2009 |
| 65162-178-89 | 10000 TABLET, EXTENDED RELEASE in 1 DRUM (65162-178-89) | Dec 2, 2009 |
Recalls mentioning this NDC
- D-1349-2020 Jul 1, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1345-2020 Jul 1, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1347-2020 Jul 1, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1344-2020 Jul 1, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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