METFORMIN HYDROCHLORIDE
- Product NDC
- 72789-400
- 11-digit product format
- 727890400
- Labeler code
- 72789
- Product ID
- 72789-400_3cf82ef5-5b60-2c45-e063-6394a90a5d62
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- metformin hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Application
- ANDA201991
- Marketing category
- ANDA
- Marketing start
- 2013-03-01
- 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 |
|---|
| 72789-400-01 | 72789040001 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-01) | 2025-01-15 | No | No | Historical |
| 72789-400-60 | 72789040060 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-60) | 2024-06-03 | No | No | Historical |
| 72789-400-82 | 72789040082 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-82) | 2024-06-03 | No | No | Historical |
| 72789-400-86 | 72789040086 | 360 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-86) | 2024-05-17 | No | No | Historical |
| 72789-400-90 | 72789040090 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-90) | 2024-05-17 | No | No | Historical |
| 72789-400-93 | 72789040093 | 180 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72789-400-93) | 2024-05-17 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| METFORMIN HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2025-08-22 | HUMAN PRESCRIPTION DRUG LABEL | 14 |