Metformin Hydrochloride
- Product NDC
- 68788-8528
- 11-digit product format
- 687888528
- Labeler code
- 68788
- Product ID
- 68788-8528_451d8f5f-5f21-4f87-8f1b-4c4159055ccf
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2023-10-06
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8528-1 | 68788852801 | 100 TABLET in 1 BOTTLE (68788-8528-1) | 100 tablet | 2023-10-06 | No | No | Historical |
| 68788-8528-3 | 68788852803 | 30 TABLET in 1 BOTTLE (68788-8528-3) | 30 tablet | 2023-10-06 | No | No | Historical |
| 68788-8528-6 | 68788852806 | 60 TABLET in 1 BOTTLE (68788-8528-6) | 60 tablet | 2023-10-06 | No | No | Historical |
| 68788-8528-8 | 68788852808 | 120 TABLET in 1 BOTTLE (68788-8528-8) | 120 tablet | 2023-10-06 | No | No | Historical |
| 68788-8528-9 | 68788852809 | 90 TABLET in 1 BOTTLE (68788-8528-9) | 90 tablet | 2023-10-06 | 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 |