CLOPIDOGREL tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL - UNII:A74586SNO7)

Available from:

Zydus Lifesciences Limited

INN (International Name):

CLOPIDOGREL BISULFATE

Composition:

CLOPIDOGREL 75 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

- Clopidogrel tablet is indicated to reduce the rate of myocardial infarction (MI) and stroke in patients with non-ST-segment elevation ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. Clopidogrel tablets should be administered in conjunction with aspirin. - Clopidogrel tablet is indicated to reduce the rate of myocardial infarction and stroke in patients with acute ST-elevation myocardial infarction (STEMI) who are to be managed medically. Clopidogrel tablets should be administered in conjunction with aspirin.  In patients with established peripheral arterial disease or with a history of recent myocardial infarction (MI) or recent stroke Clopidogrel tablet is indicated to reduce the rate of MI and stroke. Clopidogrel bisulfate is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracran

Product summary:

Clopidogrel tablets, USP equivalent to 75 mg of clopidogrel are pink-colored, biconvex, round-shaped, film-coated tablets debossed with '379' on one side and plain on the other side and are supplied as follows: NDC 70771-1062-3 in bottle of 30 tablets NDC 70771-1062-9 in bottle of 90 tablets NDC 70771-1062-5 in bottle of 500 tablets NDC 70771-1062-0 in bottle of 1,000 tablets Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Zydus Lifesciences Limited
----------
Manufactured by:
Cadila Healthcare Ltd.
India.
SPL MEDGUIDE
Revised: 10/2023
Document Id: bd428201-b17b-4773-8211-eae7e0cb7940
34391-3
Set id: 3216ebb5-00ab-403d-98e6-36c5963b1a2c
Version: 7
Effective Time: 20231003
Zydus Lifesciences Limited

Summary of Product characteristics

CLOPIDOGREL- CLOPIDOGREL TABLET, FILM COATED
ZYDUS LIFESCIENCES LIMITED
----------
CLOPIDOGREL TABLETS
Manufactured by:
Cadila Healthcare Ltd.
India.
SPL MEDGUIDE
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1062-9 in bottle of 90 Tablets
Clopidogrel Tablets USP, 75 mg
Rx only
90 TABLETS
CLOPIDOGREL
clopidogrel tablet, film coated
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1062
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
CLOPIDOGREL BISULFATE (UNII: 08I79HTP27) (CLOPIDOGREL -
UNII:A74586SNO7)
CLOPIDOGREL
75 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CROSPOVIDONE (15 MPA.S AT 5%) (UNII: 68401960MK)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
PINK (PINK)
SCORE
no score
SHAPE
ROUND (ROUND)
SIZE
9mm
FLAVOR
IMPRINT CODE
379
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1062-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2017
2
NDC:70771-
1062-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2017
3
NDC:70771-
1062-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2017
4
NDC:70771-
1062-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
02/08/2017
MARKETING INFORMATION
Zydus Lifesciences Limited
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA201686
02/08/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus