AMLODIPINE BESYLATE tablet

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)

זמין מ:

Zydus Lifesciences Limited

INN (שם בינלאומי):

AMLODIPINE BESYLATE

הרכב:

AMLODIPINE 2.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Amlodipine besylate tablets, USP are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine besylate. 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 one 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 cl

leaflet_short:

Amlodipine Besylate Tablets, USP equivalent to 2.5 mg of amlodipine are supplied as white to off-white, round, flat, radial-edged tablets debossed with 'Z' on one side and '7' on the other side and are supplied as follows: NDC 65841-620-16 in bottle of 90 tablets NDC 65841-620-01 in bottle of 100 tablets NDC 65841-620-05 in bottle of 500 tablets NDC 65841-620-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Amlodipine Besylate Tablets, USP equivalent to 5 mg of amlodipine are supplied as white to off-white, round, flat, radial-edged tablets debossed with 'Z', '3' on one side and plain on the other side and are supplied as follows: NDC 65841-621-16 in bottle of 90 tablets NDC 65841-621-01 in bottle of 100 tablets NDC 65841-621-05 in bottle of 500 tablets NDC 65841-621-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Amlodipine Besylate Tablets, USP equivalent to 10 mg of amlodipine are supplied as white to off-white, round, flat, radial-edged tablets debossed with 'Z', '5' on one side and plain on the other side and are supplied as follows: NDC 65841-622-16 in bottle of 90 tablets NDC 65841-622-01 in bottle of 100 tablets NDC 65841-622-05 in bottle of 500 tablets NDC 65841-622-77 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]. Protect from light. Dispense in a tight, light-resistant container.

מצב אישור:

Abbreviated New Drug Application

עלון מידע

Zydus Lifesciences Limited
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SPL MEDGUIDE
Revised: 9/2023
Document Id: 65386722-5517-413e-9b56-63463a0f2980
34391-3
Set id: cacb3551-c579-41cb-bed6-4b4d8b0644fc
Version: 12
Effective Time: 20230918
Zydus Lifesciences Limited

מאפייני מוצר

AMLODIPINE BESYLATE- AMLODIPINE BESYLATE TABLET
ZYDUS LIFESCIENCES LIMITED
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AMLODIPINE BESYLATE TABLETS
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 65841-620-16 in bottle of 90 tablets
Amlodipine Besylate Tablets USP, 2.5 mg
Rx only
90 tablets
NDC 65841-621-16 in bottle of 90 tablets
Amlodipine Besylate Tablets USP, 5 mg
Rx only
90 tablets
NDC 65841-622-16 in bottle of 90 tablets
Amlodipine Besylate Tablets USP, 10 mg
Rx only
90 tablets
AMLODIPINE BESYLATE
amlodipine besylate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-620
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
AMLODIPINE
2.5 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
4mm
FLAVOR
IMPRINT CODE
Z ;7
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:65841-
620-16
90 in 1 BOTTLE; Type 0: Not a Combination
Product
09/21/2007
2
NDC:65841-
620-01
100 in 1 BOTTLE; Type 0: Not a Combination
Product
09/21/2007
3
NDC:65841-
620-05
500 in 1 BOTTLE; Type 0: Not a Combination
Product
09/21/2007
4
NDC:65841-
620-77
10 in 1 CARTON
09/21/2007
4
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
ANDA078226
09/21/2007
AMLODIPINE BESYLATE
amlodipine besylate tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:65841-621
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
AMLODIPINE BESYLATE (UNII: 864V2Q084H) (AMLODIPINE - UNII:1J444QC288)
AMLODIPI