Metformin
- Product NDC
- 68788-8495
- 11-digit product format
- 687888495
- Labeler code
- 68788
- Product ID
- 68788-8495_091a22b6-63ca-4390-8611-895ffc4ea447
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin ER 500 mg
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA209313
- Marketing category
- ANDA
- Marketing start
- 2023-07-26
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 mg/1
- Pharmacologic classes
- Biguanide [EPC], Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 786Z46389E | METFORMIN HYDROCHLORIDE | 1115-70-4 | METFORMIN HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8495-1 | 68788849501 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8495-1) | 2023-07-26 | No | No | Historical |
| 68788-8495-3 | 68788849503 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8495-3) | 2023-07-26 | No | No | Historical |
| 68788-8495-6 | 68788849506 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8495-6) | 2023-07-26 | No | No | Historical |
| 68788-8495-8 | 68788849508 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8495-8) | 2023-07-26 | No | No | Historical |
| 68788-8495-9 | 68788849509 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8495-9) | 2023-07-26 | No | No | Historical |