Metformin Hydrochloride
- Product NDC
- 68788-8903
- 11-digit product format
- 687888903
- Labeler code
- 68788
- Product ID
- 68788-8903_e55ee270-5eb9-4848-8529-9af2a79669c0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA078321
- Marketing category
- ANDA
- Marketing start
- 2025-07-31
- 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 |
|---|
| 68788-8903-1 | 68788890301 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-1) | 2025-07-31 | No | No | Historical |
| 68788-8903-3 | 68788890303 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-3) | 2025-07-31 | No | No | Historical |
| 68788-8903-6 | 68788890306 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-6) | 2025-07-31 | No | No | Historical |
| 68788-8903-8 | 68788890308 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-8) | 2025-07-31 | No | No | Historical |
| 68788-8903-9 | 68788890309 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8903-9) | 2025-07-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | Preferred Pharmaceuticals Inc. | 2025-07-31 | HUMAN PRESCRIPTION DRUG LABEL | 1 |