Metformin hydrochloride
- Product NDC
- 71610-666
- 11-digit product format
- 716100666
- Labeler code
- 71610
- Product ID
- 71610-666_716a8b04-440a-4112-ab55-ba4ad134e3d8
- 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
- 2018-06-28
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 750 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 |
|---|
| 71610-666-53 | 71610066653 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-666-53) | 2023-04-11 | No | No | Historical |
| 71610-666-60 | 71610066660 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-666-60) | 2022-10-05 | No | No | Historical |
| 71610-666-80 | 71610066680 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-666-80) | 2022-10-05 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin hydrochloride ER | Aphena Pharma Solutions - Tennessee, LLC | 2023-04-14 | HUMAN PRESCRIPTION DRUG LABEL | 4 |