METFORMIN HYDROCHLORIDE
- Product NDC
- 71610-837
- 11-digit product format
- 716100837
- Labeler code
- 71610
- Product ID
- 71610-837_1a0499c1-6f4c-d51b-e063-6294a90a72fb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Aphena Pharma Solutions - Tennessee, LLC
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- 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 |
|---|
| 71610-837-30 | 71610083730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-30) | 2024-05-31 | No | No | Historical |
| 71610-837-53 | 71610083753 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-53) | 2024-05-31 | No | No | Historical |
| 71610-837-60 | 71610083760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-60) | 2024-05-31 | No | No | Historical |
| 71610-837-70 | 71610083770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-70) | 2024-05-31 | No | No | Historical |
| 71610-837-80 | 71610083780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-80) | 2024-05-31 | No | No | Historical |
| 71610-837-94 | 71610083794 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-837-94) | 2024-05-31 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METFORMIN HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2024-06-03 | HUMAN PRESCRIPTION DRUG LABEL | 1 |