MedPath
FDA Product

Glipizide ER

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

Basic Information

Glipizide ER

55289-779

Regulatory Information

55289-779

ANDA076467

C73584

September 22, 2023

USA

These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE EXTENDED-RELEASE TABLETS. GLIPIZIDE extended-release tablets, for oral use Initial U.S. Approval: 1994

HUMAN PRESCRIPTION DRUG LABEL

24

Company Information

156893695

Active Ingredients

ACETYLTRIBUTYL CITRATE

Code: 0ZBX0N59RZ

Class Code: IACT

AMMONIA

Code: 5138Q19F1X

Class Code: IACT

BUTYL ALCOHOL

Code: 8PJ61P6TS3

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)

Code: S38J6RZN16

Class Code: IACT

HYDROXYPROPYL CELLULOSE, UNSPECIFIED

Code: 9XZ8H6N6OH

Class Code: IACT

ISOPROPYL ALCOHOL

Code: ND2M416302

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)

Code: 74G4R6TH13

Class Code: IACT

GLIPIZIDE

Quantity: 5 mg in 1 1

Code: X7WDT95N5C

Class Code: ACTIB

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

SHELLAC

Code: 46N107B71O

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

Active Moieties

GLIPIZIDE

Code: X7WDT95N5C

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