PIOGLITAZONE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE - UNII:X4OV71U42S)

Available from:

Zydus Lifesciences Limited

INN (International Name):

PIOGLITAZONE HYDROCHLORIDE

Composition:

PIOGLITAZONE 15 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Monotherapy and Combination Therapy Pioglitazone tablets, USP are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see Clinical Studies (14)] . Important Limitations of Use Pioglitazone hydrochloride exerts its antihyperglycemic effect only in the presence of endogenous insulin. Pioglitazone hydrochloride should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. Use caution in patients with liver disease [see Warnings and Precautions (5.3)] . - Initiation in patients with established NYHA Class III or IV heart failure [see Boxed Warning]. - Use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone hydrochloride. Risk Summary Limited data with pioglitazone hydrochloride in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage. There are risks t

Product summary:

Pioglitazone Tablets, USP equivalent to 15 mg of pioglitazone are off-white to cream white, round flat faced beveled edge uncoated tablet debossed with "306" on one side and plain on other side and are supplied as follows: NDC 70771-1021-3 in bottle of 30 tablets NDC 70771-1021-9 in bottle of 90 tablets NDC 70771-1021-1 in bottle of 100 tablets NDC 70771-1021-5 in bottle of 500 tablets NDC 70771-1021-0 in bottle of 1000 tablets NDC 70771-1021-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pioglitazone Tablets, USP equivalent to 30 mg of pioglitazone are off-white to cream white, round flat faced beveled edge uncoated tablet debossed with "307" on one side and plain on other side and are supplied as follows: NDC 70771-1022-3 in bottle of 30 tablets NDC 70771-1022-9 in bottle of 90 tablets NDC 70771-1022-1 in bottle of 100 tablets NDC 70771-1022-5 in bottle of 500 tablets NDC 70771-1022-0 in bottle of 1000 tablets NDC 70771-1022-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets Pioglitazone Tablets, USP equivalent to 45 mg of pioglitazone are off-white to cream white, round flat faced beveled edge uncoated tablet debossed with "308" on one side and plain on other side and are supplied as follows: NDC 70771-1023-3 in bottle of 30 tablets NDC 70771-1023-9 in bottle of 90 tablets NDC 70771-1023-1 in bottle of 100 tablets NDC 70771-1023-5 in bottle of 500 tablets NDC 70771-1023-0 in bottle of 1000 tablets NDC 70771-1023-4 in unit-dose blister cartons of 100 (10 x 10) unit dose tablets STORAGE Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed, and protect from light, moisture and humidity.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: c03ba041-b002-4f31-9e0e-02951f9f7b06
34391-3
Set id: 008c5659-7430-4a9b-927f-5cb97763616a
Version: 8
Effective Time: 20230927
Zydus Lifesciences Limited

Summary of Product characteristics

PIOGLITAZONE- PIOGLITAZONE TABLET
ZYDUS LIFESCIENCES LIMITED
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PIOGLITAZONE TABLETS
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1021-3 in bottle of 30 tablets
Pioglitazone Tablets USP, 15 mg
R only
30 tablets
NDC 70771-1022-3 in bottle of 30 tablets
Pioglitazone Tablets USP, 30 mg
R only
30 tablets
x
x
NDC 70771-1023-3 in bottle of 30 tablets
Pioglitazone Tablets USP, 45 mg
R only
30 tablets
PIOGLITAZONE
x
pioglitazone tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1021
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
PIOGLITAZONE HYDROCHLORIDE (UNII: JQT35NPK6C) (PIOGLITAZONE -
UNII:X4OV71U42S)
PIOGLITAZ ONE
15 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CARBOXYMETHYLCELLULOSE CALCIUM (UNII: UTY7PDF93L)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)
PRODUCT CHARACTERISTICS
COLOR
WHITE (off-white to cream white)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
6mm
FLAVOR
IMPRINT CODE
306
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1021-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
11/16/2016
2
NDC:70771-
1021-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
11/16/2016
3
NDC:70771-
1021-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
11/16/2016
4
NDC:70771-
1021-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
11/16/2016
5
NDC:70771-
1021-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
11/16/2016
6
NDC:70771-
1021-4
10 in 1 CARTON
11/16/2016
6
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
APPLICATION NUMBER OR MONOGRAPH
MARKETING START
MARKETING END
CATEGORY
CITATION
DATE
DATE
ANDA
ANDA202456
11/16/2016
PIOGLITAZONE
pioglitazone tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1022
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY