Glyburide and Metformin Hydrochloride

Product NDC
68788-9128
11-digit product format
687889128
Labeler code
68788
Product ID
68788-9128_b0abd953-5e39-4354-9c0f-0de17f9d06ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Glyburide and Metformin Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076716
Marketing category
ANDA
Marketing start
2005-06-28
Marketing end
0000-00-00
Substance
GLYBURIDE; METFORMIN HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Sulfonylurea [EPC],Sulfonylurea Compounds [CS],Biguanide [EPC],Biguanides [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#