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Glipizide

Glipizide

Approved
Approval ID

907a49d2-95e4-ae71-e053-2a95a90ae23a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 19, 2019

Manufacturers
FDA

Direct_Rx

DUNS: 079254320

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 Code61919-715
Application NumberANDA204720
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 19, 2019
FDA Product Classification

INGREDIENTS (14)

POLYETHYLENE OXIDE 200000Inactive
Code: 11628IH70O
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GLIPIZIDEActive
Quantity: 10 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
HYPROMELLOSE 2910 (15 MPA.S)Inactive
Code: 36SFW2JZ0W
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
POLYETHYLENE GLYCOL 7000000Inactive
Code: G3MS6M810Y
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

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Glipizide - FDA Drug Approval Details