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FDA Drug information

Glipizide

Read time: 1 mins
Marketing start date: 02 May 2024
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Summary of product characteristics


Effective Time

20221013

Version

5

Spl Product Data Elements

Glipizide Glipizide GLIPIZIDE GLIPIZIDE ACETYLTRIBUTYL CITRATE ALUMINUM OXIDE AMMONIA BUTYL ALCOHOL FD&C YELLOW NO. 5 FERROSOFERRIC OXIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES ISOPROPYL ALCOHOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE TITANIUM DIOXIDE Yellow Round 2 Glipizide Glipizide GLIPIZIDE GLIPIZIDE ACETYLTRIBUTYL CITRATE AMMONIA BUTYL ALCOHOL FD&C YELLOW NO. 6 FERROSOFERRIC OXIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES ISOPROPYL ALCOHOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE TITANIUM DIOXIDE Orange Round 3 Glipizide Glipizide GLIPIZIDE GLIPIZIDE ACETYLTRIBUTYL CITRATE AMMONIA BUTYL ALCOHOL FERROSOFERRIC OXIDE HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) HYDROXYPROPYL CELLULOSE, UNSPECIFIED HYPROMELLOSES ISOPROPYL ALCOHOL LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL SHELLAC SILICON DIOXIDE White Round 4

Application Number

ANDA203499

Brand Name

Glipizide

Generic Name

Glipizide

Product Ndc

70771-1098

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1098-3 in bottle of 30 tablets Glipizide Tablets, 2.5 mg R x only 30 tablets ZYDUS NDC 70771-1099-3 in bottle of 30 tablets Glipizide Tablets, 5 mg R x only 30 tablets ZYDUS NDC 70771-1100-3 in bottle of 30 tablets Glipizide Tablets, 10 mg R x only 30 tablets ZYDUS Glipizide ER Tablets Glipizide ER Tablets Glipizide ER Tablets

Drug section

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