Metformin hydrochloride
- Product NDC
- 71610-587
- 11-digit product format
- 716100587
- Labeler code
- 71610
- Product ID
- 71610-587_0f023696-fd07-41a2-8f06-bf3472b28de2
- 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
- 2018-07-17
- 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 |
|---|
| 71610-587-30 | 71610058730 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-30) | 2022-01-18 | No | No | Historical |
| 71610-587-60 | 71610058760 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-60) | 2021-07-28 | No | No | Historical |
| 71610-587-70 | 71610058770 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-70) | 2021-07-28 | No | No | Historical |
| 71610-587-80 | 71610058780 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-80) | 2021-07-28 | No | No | Historical |
| 71610-587-92 | 71610058792 | 270 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-92) | 2022-01-18 | No | No | Historical |
| 71610-587-94 | 71610058794 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE (71610-587-94) | 2021-07-28 | No | No | Historical |