Glipizide
GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only
Approved
Approval ID
116ffc6a-735c-49e0-a9d5-69b6bc3e3706
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
Legacy Pharmaceutical Packaging, LLC
DUNS: 143213275
Products 2
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 Code68645-574
Application NumberANDA075795
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (5)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLIPIZIDEActive
Quantity: 5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
Glipizide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68645-575
Application NumberANDA075795
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (5)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GLIPIZIDEActive
Quantity: 10 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT