Metformin Hydrochloride
- Product NDC
- 47335-305
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA202917
- Marketing category
- ANDA
- Substance
- METFORMIN HYDROCHLORIDE
- Current FDA listing
- Yes
Packages
| Package NDC | Description | Marketing start | Marketing end | Sample | Status |
|---|
| 47335-305-18 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-18) | 20180522 | | No | Historical |
| 47335-305-83 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-83) | 20180522 | | No | Historical |
| 47335-305-88 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-305-88) | 20180522 | | No | Historical |
Related DailyMed Labels
| Set ID | Title | Manufacturer | Effective date | Type | Version |
|---|
| 52c18b5c-2322-4b22-a36e-3c573d609dd0 | These highlights do not include all the information needed to use METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS. METFORMIN HYDROCHLORIDE extended-release tablets, for oral use Initial U.S. Approval: 1995 | Sun Pharmaceutical Industries, Inc. | Sun Pharmaceutical Industries Limited | 2024-01-09 | Human Prescription Drug Label | 11 |