Glipizide
Approved
Approval ID
6ce1d9b9-3a71-4c10-9c09-6259088baafb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 15, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-5210
Application NumberANDA076467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2010
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLIPIZIDEActive
Quantity: 5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4988
Application NumberANDA076467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2010
FDA Product Classification
INGREDIENTS (8)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
GLIPIZIDEActive
Quantity: 10 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5364
Application NumberANDA076467
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2010
FDA Product Classification
INGREDIENTS (9)
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
GLIPIZIDEActive
Quantity: 2.5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
ACETYLTRIBUTYL CITRATEInactive
Code: 0ZBX0N59RZ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT