Ezetimibe (Page 7 of 7)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 67877-490-30
Ezetimibe Tablets, USP 10mg
Rx Only 30 Tablets

ezetimibe-10mg-30tab-a
(click image for full-size original)

NDC 67877-490-90
Ezetimibe Tablets, USP 10mg
Rx Only 90 Tablets
ezetimibe-10mg-90tab-a
(click image for full-size original)

NDC 67877-490-01
Ezetimibe Tablets, USP 10mg
Rx Only 100 Tablets
ezetimibe-10mg-100tab-a
(click image for full-size original)

NDC 67877-490-05
Ezetimibe Tablets, USP 10mg
Rx Only 500 Tablets
ezetimibe-10mg-500tab-a
(click image for full-size original)

EZETIMIBE ezetimibe tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-490
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
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
SODIUM LAURYL SULFATE
CROSPOVIDONE, UNSPECIFIED
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape OVAL (Capsule shaped) Size 8mm
Flavor Imprint Code A25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-490-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-490-90 90 TABLET in 1 BOTTLE None
3 NDC:67877-490-05 500 TABLET in 1 BOTTLE None
4 NDC:67877-490-55 5000 TABLET in 1 BOTTLE None
5 NDC:67877-490-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209234 12/23/2017
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 677605851 ANALYSIS (67877-490), MANUFACTURE (67877-490), PACK (67877-490)

Revised: 05/2023 Ascend Laboratories, LLC

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.