glyburide and metformin hydrochloride
- Product NDC
- 71335-0127
- 11-digit product format
- 713350127
- Labeler code
- 71335
- Product ID
- 71335-0127_8398abf3-517a-49dc-99c6-d1ce647fca81
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glyburide and metformin hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA206748
- Marketing category
- ANDA
- Marketing start
- 2016-04-07
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 3 mg/1; mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-0127-1 | 71335012701 | 100 TABLET in 1 BOTTLE (71335-0127-1) | 100 tablet | 2017-08-23 | 0000-00-00 | No | No | Current |
| 71335-0127-2 | 71335012702 | 30 TABLET in 1 BOTTLE (71335-0127-2) | 30 tablet | 2017-08-23 | 0000-00-00 | No | No | Current |
| 71335-0127-3 | 71335012703 | 60 TABLET in 1 BOTTLE (71335-0127-3) | 60 tablet | 2017-08-23 | 0000-00-00 | No | No | Current |
| 71335-0127-4 | 71335012704 | 90 TABLET in 1 BOTTLE (71335-0127-4) | 90 tablet | 2017-08-23 | 0000-00-00 | No | No | Current |
| 71335-0127-5 | 71335012705 | 180 TABLET in 1 BOTTLE (71335-0127-5) | 180 tablet | 2017-08-23 | 0000-00-00 | No | No | Current |