Metformin Hydrochloride
- Product NDC
- 71610-941
- 11-digit product format
- 716100941
- Labeler code
- 71610
- Product ID
- 71610-941_3d451d25-9aba-a066-e063-6394a90a86b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA077095
- Marketing category
- ANDA
- Marketing start
- 2024-03-29
- 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 |
|---|
| 71610-941-60 | 71610094160 | 90 TABLET, FILM COATED in 1 BOTTLE (71610-941-60) | 2025-08-25 | No | No | Historical |
| 71610-941-80 | 71610094180 | 180 TABLET, FILM COATED in 1 BOTTLE (71610-941-80) | 2025-08-25 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | 2025-08-26 | HUMAN PRESCRIPTION DRUG LABEL | 1 |