Metformin hydrochloride
- Product NDC
- 71610-858
- 11-digit product format
- 716100858
- Labeler code
- 71610
- Product ID
- 71610-858_24255d3b-67ec-67fa-e063-6394a90a151d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA207427
- Marketing category
- ANDA
- Marketing start
- 2024-06-11
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 500 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 |
|---|
| 71610-858-30 | 71610085830 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-858-30) | 2024-10-10 | No | No | Historical |
| 71610-858-53 | 71610085853 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-858-53) | 2024-10-10 | No | No | Historical |
| 71610-858-60 | 71610085860 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-858-60) | 2024-10-10 | No | No | Historical |
| 71610-858-70 | 71610085870 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-858-70) | 2024-10-10 | No | No | Historical |
| 71610-858-80 | 71610085880 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-858-80) | 2024-10-10 | No | No | Historical |
| 71610-858-94 | 71610085894 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-858-94) | 2024-10-10 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | 2024-10-10 | HUMAN PRESCRIPTION DRUG LABEL | 1 |