Metformin hydrochloride
- Product NDC
- 71610-554
- 11-digit product format
- 716100554
- Labeler code
- 71610
- Product ID
- 71610-554_91ab7bd9-ef80-437c-967b-3f11991c2139
- 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 |
|---|
| 71610-554-30 | 71610055430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-30) | 2021-05-12 | No | No | Historical |
| 71610-554-53 | 71610055453 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-53) | 2022-01-31 | No | No | Historical |
| 71610-554-60 | 71610055460 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-60) | 2021-05-12 | No | No | Historical |
| 71610-554-70 | 71610055470 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-70) | 2021-06-09 | No | No | Historical |
| 71610-554-80 | 71610055480 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-80) | 2022-01-18 | No | No | Historical |
| 71610-554-92 | 71610055492 | 270 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-92) | 2021-06-18 | No | No | Historical |
| 71610-554-94 | 71610055494 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71610-554-94) | 2021-08-18 | No | No | Historical |