METFORMIN HYDROCHLORIDE
- Product NDC
- 68788-8532
- 11-digit product format
- 687888532
- Labeler code
- 68788
- Product ID
- 68788-8532_c7571e06-7334-4c30-be0e-35a624f183bb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- METFORMIN HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA077336
- Marketing category
- ANDA
- Marketing start
- 2023-10-03
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 |
|---|
| 68788-8532-1 | 68788853201 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8532-1) | 2023-10-03 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METFORMIN HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 2025-08-06 | HUMAN PRESCRIPTION DRUG LABEL | 3 |