Metformin Hydrochloride
- Product NDC
- 50090-5397
- 11-digit product format
- 500905397
- Labeler code
- 50090
- Product ID
- 50090-5397_d54849ef-363f-43c5-ab89-c491f90fea0d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA206145
- Marketing category
- ANDA
- Marketing start
- 2018-10-27
- 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 |
|---|
| 50090-5397-0 | 50090539700 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-5397-0) | 2020-12-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | A-S Medication Solutions | 2023-09-18 | Human Prescription Drug Label | 4 |