Metformin Hydrochloride
- Product NDC
- 63629-5934
- 11-digit product format
- 636295934
- Labeler code
- 63629
- Product ID
- 63629-5934_2a3df1c0-40b3-4a51-8dde-1d22077aa5aa
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA090692
- Marketing category
- ANDA
- Marketing start
- 2011-09-30
- Substance
- METFORMIN HYDROCHLORIDE
- Active strength
- 1000 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 |
|---|
| 63629-5934-1 | 63629593401 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-5934-1) | 2025-06-02 | No | No | Historical |
| 63629-5934-2 | 63629593402 | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-5934-2) | 2025-06-02 | No | No | Historical |
| 63629-5934-3 | 63629593403 | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-5934-3) | 2025-06-02 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Metformin Hydrochloride | Bryant Ranch Prepack | 2025-06-02 | HUMAN PRESCRIPTION DRUG LABEL | 1 |