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Glipizide

GLIPIZIDE TABLETS, USP 5 mg and 10 mg Rx Only

Approved
Approval ID

6282c653-9e9c-6810-e053-2991aa0a4a8e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 23, 2022

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

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 Code68071-4223
Application NumberANDA075795
Product Classification
M
Marketing Category
C73584
G
Generic Name
Glipizide
Product Specifications
Route of AdministrationORAL
Effective DateAugust 23, 2022
FDA Product Classification

INGREDIENTS (5)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
GLIPIZIDEActive
Quantity: 5 mg in 1 1
Code: X7WDT95N5C
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT

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Glipizide - FDA Drug Approval Details