NDC 72789-009 – Metformin Hydrochloride Extended Release
Metformin Hydrochloride 500 mg/1 · Tablet, Extended Release · Oral
Product NDC72789-009
Product details
- Brand name
- Metformin Hydrochloride Extended Release
- Generic name
- Metformin Hydrochloride
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Dosage form
- Tablet, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA090295
- Marketed since
- May 12, 2016
- Listing expires
- December 31, 2027
- Pharmacologic class
- Biguanide
Active ingredients
- Metformin Hydrochloride 500 mg/1
Uses, dosage, side effects and warnings for Metformin Hydrochloride Extended Release →
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 72789-009-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-30) | Sep 18, 2019 |
| 72789-009-60 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-60) | Sep 20, 2019 |
| 72789-009-90 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-90) | Sep 13, 2019 |
| 72789-009-93 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-009-93) | Sep 13, 2019 |
Recalls mentioning this NDC
- D-0059-2021 Nov 11, 2020 · Class II
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer) - D-1333-2020 Jul 1, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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