Glyburide and Metformin Hydrochloride
- Product NDC
- 0115-1648
- 11-digit product format
- 001151648
- Labeler code
- 0115
- Product ID
- 0115-1648_5531ac0a-ef76-41f1-9845-f3d1f6bd82dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glyburide and Metformin Hydrochloride
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Impax Generics
- Application
- ANDA076716
- Marketing category
- ANDA
- Marketing start
- 2016-08-03
- Marketing end
- 0000-00-00
- Substance
- GLYBURIDE; METFORMIN HYDROCHLORIDE
- Active strength
- 1 mg/1; mg/1
- Pharmacologic classes
- Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
- NDC exclude flag
- No
- Listing certified through
- 2019-12-31
- Current FDA listing
- Historical FDA.report record