NDC 70010-491 – Metformin
Metformin Hydrochloride 500 mg/1 · Tablet, Extended Release · Oral
Product NDC70010-491
Product details
- Brand name
- Metformin
- Generic name
- Metformin ER 500 mg
- Labeler
- Granules Pharmaceuticals Inc.
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA209313
- Marketed since
- July 31, 2018
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide
Active ingredients
- Metformin Hydrochloride 500 mg/1
Package NDC codes (6)
| Package NDC | Description | Since |
|---|---|---|
| 70010-491-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-01) | Jul 31, 2018 |
| 70010-491-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-05) | Jul 31, 2018 |
| 70010-491-09 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-09) | Apr 16, 2020 |
| 70010-491-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (70010-491-10) | Jul 31, 2018 |
| 70010-491-18 | 5000 TABLET, EXTENDED RELEASE in 1 POUCH (70010-491-18) | Jun 14, 2019 |
| 70010-491-19 | 25000 TABLET, EXTENDED RELEASE in 1 CARTON (70010-491-19) | Jun 14, 2019 |
Recalls mentioning this NDC
- D-1386-2020 Jul 22, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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