METFORMIN HYDROCHLORIDE
- Product NDC
- 68071-3531
- 11-digit product format
- 680713531
- Labeler code
- 68071
- Product ID
- 68071-3531_2d3f9c43-31df-2883-e063-6294a90a7742
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA213320
- Marketing category
- ANDA
- Marketing start
- 2023-01-19
- 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 |
|---|
| 68071-3531-1 | 68071353101 | 100 TABLET in 1 BOTTLE (68071-3531-1) | 100 tablet | 2023-11-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METFORMIN HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 2025-02-03 | HUMAN PRESCRIPTION DRUG LABEL | 2 |