Glipizide
Glipizide Extended-Release Tablets Rx only
Approved
Approval ID
289bda32-6198-4072-a9f3-283438bda707
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-967
Application NumberANDA076467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateMarch 18, 2011
FDA Product Classification
INGREDIENTS (15)
GLIPIZIDEActive
Quantity: 2.5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)Inactive
Code: S38J6RZN16
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT