GLIPIZIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)

Available from:

Zydus Lifesciences Limited

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Glipizide is contraindicated in patients with: - Known hypersensitivity to glipizide or any of the product's ingredients. - Hypersensitivity to sulfonamide derivatives. Risk Summary Available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Clinical Consideration

Product summary:

Glipizide Extended-release Tablets, 2.5 mg are yellow colored, round, biconvex film-coated tablets imprinted with "2" on one side with black ink and plain on the other side and are supplied as follows: NDC 70771-1098-3 in bottle of 30 tablets NDC 70771-1098-6 in bottle of 60 tablets NDC 70771-1098-9 in bottle of 90 tablets NDC 70771-1098-1 in bottle of 100 tablets NDC 70771-1098-5 in bottle of 500 tablets NDC 70771-1098-0 in bottle of 1000 tablets NDC 70771-1098-4 in cartons of 100 tablets (10 x 10 unit-dose) Glipizide Extended-release Tablets, 5 mg are orange colored, round, biconvex film-coated tablets imprinted with "3" on one side with black ink and plain on the other side and are supplied as follows: NDC 70771-1099-3 in bottle of 30 tablets NDC 70771-1099-6 in bottle of 60 tablets NDC 70771-1099-9 in bottle of 90 tablets NDC 70771-1099-1 in bottle of 100 tablets NDC 70771-1099-5 in bottle of 500 tablets NDC 70771-1099-0 in bottle of 1000 tablets NDC 70771-1099-4 in cartons of 100 tablets (10 x 10 unit-dose) Glipizide Extended-release Tablets, 10 mg are white colored, round, biconvex film-coated tablets imprinted with "4" on one side and plain on the other side and are supplied as follows: NDC 70771-1100-3 in bottle of 30 tablets NDC 70771-1100-6 in bottle of 60 tablets NDC 70771-1100-9 in bottle of 90 tablets NDC 70771-1100-1 in bottle of 100 tablets NDC 70771-1100-5 in bottle of 500 tablets NDC 70771-1100-0 in bottle of 1000 tablets NDC 70771-1100-4 in cartons of 100 tablets (10 x 10 unit-dose) Storage: The tablets should be protected from moisture and humidity. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GLIPIZIDE - GLIPIZIDE TABLET, EXTENDED RELEASE
ZYDUS LIFESCIENCES LIMITED
----------
GLIPIZIDE EXTENDED-RELEASE TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1098-3 in bottle of 30 tablets
Glipizide Tablets, 2.5 mg
R only
30 tablets
ZYDUS
NDC 70771-1099-3 in bottle of 30 tablets
Glipizide Tablets, 5 mg
R only
30 tablets
ZYDUS
x
x
NDC 70771-1100-3 in bottle of 30 tablets
Glipizide Tablets, 10 mg
R only
30 tablets
ZYDUS
GLIPIZIDE
glipizide tablet, extended release
PRODUCT INFORMATION
x
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1098
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)
GLIPIZ IDE
2.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)
ALUMINUM OXIDE (UNII: LMI26O6933)
AMMONIA (UNII: 5138Q19F1X)
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII:
74G4R6TH13)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SHELLAC (UNII: 46N107B71O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PRODUCT CHARACTERISTICS
COLOR
YELLOW (Yellow)
SCORE
no score
SHAPE
ROUND (Round)
SIZE
6mm
FLAVOR
IMPRINT CODE
2
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1098-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
07/25/2018
2
NDC:70771-
1098-6
60 in 1 BOTTLE; Type 0: Not a Combination
Product
07/25/2018
3
NDC:70771-
1098-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
07/25/2018
4
NDC:70771-
1098-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product