FDA Product

Glipizide

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Glipizide

FDA Product Code

53217-317

Regulatory Information

NDC Product Code

53217-317

Application Number

ANDA074550

Marketing Category

C73584

Effective Date

May 25, 2017

Territorial Authority

USA

FDA Title

GLIPIZIDE TABLETS, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

1

Company Information

ManufacturerAidarex Pharmaceuticals LLC

DUNS Number

801503249

Active Ingredients

ANHYDROUS LACTOSE

Code: 3SY5LH9PMK

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Quantity: 5 mg in 1 1

Code: X7WDT95N5C

Class Code: ACTIB

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

GLIPIZIDE

Code: X7WDT95N5C

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