METFORMIN HYDROCHLORIDE
- Product NDC
- 67046-1516
- 11-digit product format
- 670461516
- Labeler code
- 67046
- Product ID
- 67046-1516_2d7d92eb-4d87-f72b-e063-6294a90ac932
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA213320
- Marketing category
- ANDA
- Marketing start
- 2025-02-06
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 |
|---|
| 67046-1516-3 | 67046151603 | 30 TABLET in 1 BLISTER PACK (67046-1516-3) | 30 tablet | 2025-02-06 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METFORMIN HYDROCHLORIDE | Coupler LLC | 2025-02-06 | HUMAN PRESCRIPTION DRUG LABEL | 1 |