METFORMIN HYDROCHLORIDE
- Product NDC
- 68788-8814
- 11-digit product format
- 687888814
- Labeler code
- 68788
- Product ID
- 68788-8814_4adeddf2-f449-4a61-9658-dfbff7c50230
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2025-01-21
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- METFORMIN HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| METFORMIN HYDROCHLORIDE | 500 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 860975 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8814-1 | 68788881401 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8814-1) | 2025-01-21 | No | No | Historical |
| 68788-8814-3 | 68788881403 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8814-3) | 2025-01-21 | No | No | Historical |
| 68788-8814-6 | 68788881406 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8814-6) | 2025-01-21 | No | No | Historical |
| 68788-8814-8 | 68788881408 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8814-8) | 2025-01-21 | No | No | Historical |
| 68788-8814-9 | 68788881409 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8814-9) | 2025-01-21 | No | No | Historical |