Ezetimibe

EZETIMIBE- ezetimibe tablet
Cadila Healthcare Limited

NDC 70771-1109-3 in bottle of 30 tablets

Ezetimibe Tablets , 10 mg

Rx only

30 tablets

Ezetimibe Tablets, 10 mg
(click image for full-size original)
EZETIMIBE
ezetimibe tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1109
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
POVIDONE
SODIUM LAURYL SULFATE
SODIUM STEARYL FUMARATE
STARCH, CORN
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 Multilevel Packaging
1 NDC:70771-1109-3 30 TABLET in 1 BOTTLE None
2 NDC:70771-1109-9 90 TABLET in 1 BOTTLE None
3 NDC:70771-1109-1 100 TABLET in 1 BOTTLE None
4 NDC:70771-1109-5 500 TABLET in 1 BOTTLE None
5 NDC:70771-1109-0 1000 TABLET in 1 BOTTLE None
6 NDC:70771-1109-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1109-2)
6 NDC:70771-1109-2 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (70771-1109-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204331 08/09/2017
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (918596198)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 918596198 ANALYSIS (70771-1109), MANUFACTURE (70771-1109)

Revised: 08/2020 Cadila Healthcare Limited

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