EZETIMIBE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)

Available from:

Zydus Lifesciences Limited

INN (International Name):

EZETIMIBE

Composition:

EZETIMIBE 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Monotherapy Ezetimibe Tablets, administered alone, are indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia. Combination Therapy with HMG-CoA Reductase Inhibitors (Statins) Ezetimibe Tablets, administered in combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin), is indicated as adjunctive therapy to diet for the reduction of ele

Product summary:

Ezetimibe Tablets USP, 10 mg are white to off-white, capsule-shape, flat-face beveled edge uncoated tablets debossed with '773' on one side and plain on other side and are supplied as follows: NDC 70771-1109-3 in bottle of 30 tablets NDC 70771-1109-9 in bottle of 90 tablets NDC 70771-1109-1 in bottle of 100 tablets NDC 70771-1109-5 in bottle of 500 tablets NDC 70771-1109-0 in bottle of 1000 tablets NDC 70771-1109-4 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]. Protect from moisture. Dispense in a tightly closed container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

EZETIMIBE - EZETIMIBE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
EZETIMIBE TABLETS
NDC 70771-1109-3 in bottle of 30 tablets
Ezetimibe Tablets , 10 mg
Rx only
30 tablets
EZETIMIBE
ezetimibe tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1109
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
EZETIMIBE (UNII: EOR26LQQ24) (EZETIMIBE - UNII:EOR26LQQ24)
EZ ETIMIBE
10 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSPOVIDONE (UNII: 2S7830E561)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
Zydus Lifesciences Limited
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM STEARYL FUMARATE (UNII: 7CV7WJK4UI)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
9mm
FLAVOR
IMPRINT CODE
773
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1109-3
30 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
2
NDC:70771-
1109-9
90 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
3
NDC:70771-
1109-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
4
NDC:70771-
1109-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
5
NDC:70771-
1109-0
1000 in 1 BOTTLE; Type 0: Not a Combination
Product
08/09/2017
6
NDC:70771-
1109-4
10 in 1 CARTON
08/09/2017
6
NDC:70771-
1109-2
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
ANDA204331
08/09/2017
LABELER -
Zydus Lifesciences Limited (918596198)
REGISTRANT -
Zydus Lifesciences Limited (918596198)
ESTABLISHMENT
NAME
ADDRESS
ID/FEI
BUSINESS OPERATIONS
Zydus Lifesciences Limited
918596198
ANALYSIS(70771-1109) , MANUFACTURE(70771-1109)
Revised: 8/2022