IRBESARTAN tablet

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)

Disponible des:

Zydus Lifesciences Limited

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Irbesartan tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular (CV) events, primarily strokes and myocardial infarction. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than 1 drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with differe

Resumen del producto:

Irbesartan Tablets USP, 75 mg are white to off-white, biconvex, capsule-shaped tablet debossed with "ZE53" on one side and plain on other side and are supplied as follows:   NDC 70771-1159-3 in bottle of 30 tablets NDC 70771-1159-9 in bottle of 90 tablets NDC 70771-1159-5 in bottle of 500 tablets NDC 70771-1159-0 in bottle of 1,000 tablets NDC 70771-1159-4 in carton of 100 tablets (10 x 10 unit-dose)   Irbesartan Tablets USP, 150 mg are white to off-white, biconvex, capsule-shaped tablet debossed with "ZE54" on one side and plain on other side and are supplied as follows:   NDC 70771-1160-3 in bottle of 30 tablets NDC 70771-1160-9 in bottle of 90 tablets NDC 70771-1160-5 in bottle of 500 tablets NDC 70771-1160-0 in bottle of 1,000 tablets NDC 70771-1160-4 in carton of 100 tablets (10 x 10 unit-dose)   Irbesartan Tablets USP, 300 mg are white to off-white, biconvex, capsule-shaped tablet debossed with "ZE55" on one side and plain on other side and are supplied as follows:   NDC 70771-1161-3 in bottle of 30 tablets NDC 70771-1161-9 in bottle of 90 tablets NDC 70771-1161-5 in bottle of 500 tablets NDC 70771-1161-0 in bottle of 1,000 tablets NDC 70771-1161-4 in carton of 100 tablets (10 x 10 unit-dose)

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

IRBESARTAN - IRBESARTAN TABLET
ZYDUS LIFESCIENCES LIMITED
----------
IRBESARTAN TABLETS
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1159-0 in bottles of 1000 tablets
Irbesartan Tablets USP, 75 mg
1000 Tablets
Rx Only
NDC 70771-1160-0 in bottles of 1000 tablets
Irbesartan Tablets USP, 150 mg
1000 Tablets
Rx Only
NDC 70771-1161-0 in bottles of 1000 tablets
Irbesartan Tablets USP, 300 mg
1000 Tablets
Rx Only
IRBESARTAN
irbesartan tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1159
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
IRBESARTAN (UNII: J0E2756Z7N) (IRBESARTAN - UNII:J0E2756Z7N)
IRBESARTAN
75 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CALCIUM STEARATE (UNII: 776XM7047L)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
POLOXAMER 188 (UNII: LQA7B6G8JG)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
11mm
FLAVOR
IMPRINT CODE
Z E53
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1159-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
12/08/2017
2
NDC:70771-
1159-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
12/08/2017
3
NDC:70771-
1159-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
12/08/2017
4
NDC:70771-
1159-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
12/08/2017
5
NDC:70771-
1159-4
10 in 1 CARTON
12/08/2017
5
NDC:70771-
1159-2
10 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA079213
12/08/2017
IRBESARTAN
irbesartan tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1160
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
IRBESARTAN (UN