Glipizide
Glipizide Tablets USPRevised: November 2008Rx only 174347
Approved
Approval ID
0a280a88-5973-4d0f-9b25-9be0c96e49c7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 15, 2011
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-822
Application NumberANDA074223
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 27, 2010
FDA Product Classification
INGREDIENTS (7)
GLIPIZIDEActive
Quantity: 10 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT