NDC 49483-624 – Metformin Hydrochloride Extended Release
Metformin Hydrochloride 750 mg/1 · Tablet, Extended Release · Oral
Product NDC49483-624
Product details
- Brand name
- Metformin Hydrochloride Extended Release
- Generic name
- Metformin Hydrochloride
- Labeler
- TIME CAP LABORATORIES, 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 750 mg/1
Uses, dosage, side effects and warnings for Metformin Hydrochloride Extended Release →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 49483-624-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-624-01) | May 12, 2016 |
| 49483-624-50 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (49483-624-50) | May 12, 2016 |
Recalls mentioning this NDC
- D-0062-2021 Nov 11, 2020 · Class II
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-0061-2021 Nov 11, 2020 · Class II
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level - D-1356-2020 Jul 1, 2020 · Class II
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
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