Metformin Hydrochloride
- Product NDC
- 67046-1554
- 11-digit product format
- 670461554
- Labeler code
- 67046
- Product ID
- 67046-1554_32ff4103-c2ac-d83a-e063-6394a90a97cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Coupler, LLC
- Application
- ANDA205096
- Marketing category
- ANDA
- Marketing start
- 2025-04-17
- 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 | Marketing start | Sample | Exclude flag | Status |
|---|
| 67046-1554-3 | 67046155403 | 30 TABLET, COATED in 1 BLISTER PACK (67046-1554-3) | 2025-04-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | Coupler, LLC | Coupler LLC | 2025-04-17 | HUMAN PRESCRIPTION DRUG LABEL | 1 |