Metformin HCl
- Product NDC
- 71205-562
- 11-digit product format
- 712050562
- Labeler code
- 71205
- Product ID
- 71205-562_09678d2f-39cd-4821-bcac-3ecdc853f822
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin HCl
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA090564
- Marketing category
- ANDA
- Marketing start
- 2017-02-06
- 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
openFDA Listing Details
- Product ID
- 71205-562_09678d2f-39cd-4821-bcac-3ecdc853f822
- SPL ID
- 09678d2f-39cd-4821-bcac-3ecdc853f822
- Product type
- HUMAN PRESCRIPTION DRUG
- Finished product
- Yes
- Brand name base
- Metformin HCl
- Generic name
- Metformin HCl
- Dosage form
- TABLET
- Route
- ORAL
- Marketing start
- 2017-02-06
- Marketing category
- ANDA
- Application number
- ANDA090564
- Pharmacologic classes
- Biguanide [EPC]; Biguanides [CS]
- Listing expiration
- 2026-12-31
openFDA Active Ingredients
| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
openFDA Harmonized Identifiers
| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861007, 861010 |
| Spl Set Id | d2c927eb-12bf-4c7d-9ef5-0036b2dd8c29 |
| Manufacturer Name | Proficient Rx LP |
openFDA Package Details
| Package NDC | Description | Marketing start | Sample |
|---|
| 71205-562-00 | 100 TABLET in 1 BOTTLE (71205-562-00) | 2021-06-23 | No |
| 71205-562-30 | 30 TABLET in 1 BOTTLE (71205-562-30) | 2021-05-17 | No |
| 71205-562-60 | 60 TABLET in 1 BOTTLE (71205-562-60) | 2021-05-17 | No |
| 71205-562-90 | 90 TABLET in 1 BOTTLE (71205-562-90) | 2021-05-17 | No |
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 | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 71205-562-00 | 71205056200 | 100 TABLET in 1 BOTTLE (71205-562-00) | 100 tablet | 2021-06-23 | No | No | Historical |
| 71205-562-30 | 71205056230 | 30 TABLET in 1 BOTTLE (71205-562-30) | 30 tablet | 2021-05-17 | No | No | Historical |
| 71205-562-60 | 71205056260 | 60 TABLET in 1 BOTTLE (71205-562-60) | 60 tablet | 2021-05-17 | No | No | Historical |
| 71205-562-90 | 71205056290 | 90 TABLET in 1 BOTTLE (71205-562-90) | 90 tablet | 2021-05-17 | No | No | Historical |