METFORMIN HYDROCHLORIDE
- Product NDC
- 68788-8603
- 11-digit product format
- 687888603
- Labeler code
- 68788
- Product ID
- 68788-8603_69d34800-a547-43db-b82e-ad8819118e8d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals Inc.
- Application
- ANDA213320
- Marketing category
- ANDA
- Marketing start
- 2024-03-11
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 850 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 | 850 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 786Z46389E |
| Rxcui | 861010 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68788-8603-1 | 68788860301 | 100 TABLET in 1 BOTTLE (68788-8603-1) | 100 tablet | 2024-03-11 | No | No | Historical |
| 68788-8603-3 | 68788860303 | 30 TABLET in 1 BOTTLE (68788-8603-3) | 30 tablet | 2024-03-11 | No | No | Historical |
| 68788-8603-6 | 68788860306 | 60 TABLET in 1 BOTTLE (68788-8603-6) | 60 tablet | 2024-03-11 | No | No | Historical |
| 68788-8603-8 | 68788860308 | 120 TABLET in 1 BOTTLE (68788-8603-8) | 120 tablet | 2024-03-11 | No | No | Historical |
| 68788-8603-9 | 68788860309 | 90 TABLET in 1 BOTTLE (68788-8603-9) | 90 tablet | 2024-03-11 | No | No | Historical |