Ezetimibe and Simvastatin (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASCEND Laboratories, LLC
NDC 67877-507-30
Ezetimibe and Simvastatin Tablets 10 mg/10 mg
Rx only
30 Tablets

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

ASCEND Laboratories, LLC
NDC 67877-508-01
Ezetimibe and Simvastatin Tablets 10 mg/20 mg
Rx only
1,000 Tablets

es-10mg-20mg-1000tab-a
(click image for full-size original)

ASCEND Laboratories, LLC
NDC 67877-509-90
Ezetimibe and Simvastatin Tablets 10 mg/40 mg
Rx only
90 Tablets

es-10mg-40mg-90tab-a
(click image for full-size original)

ASCEND Laboratories, LLC
NDC 67877-510-05
Ezetimibe and Simvastatin Tablets 10 mg/80 mg
Rx only
500 Tablets

es-10mg-80mg-500tab-a
(click image for full-size original)
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-507
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
PROPYL GALLATE
BUTYLATED HYDROXYANISOLE
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
WATER
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 8mm
Flavor Imprint Code A029
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-507-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-507-90 90 TABLET in 1 BOTTLE None
3 NDC:67877-507-01 1000 TABLET in 1 BOTTLE None
4 NDC:67877-507-38 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (67877-507-33)
4 NDC:67877-507-33 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67877-507-38)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209222 12/24/2017
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-508
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
PROPYL GALLATE
BUTYLATED HYDROXYANISOLE
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
WATER
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code A028
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-508-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-508-90 90 TABLET in 1 BOTTLE None
3 NDC:67877-508-01 1000 TABLET in 1 BOTTLE None
4 NDC:67877-508-38 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (67877-508-33)
4 NDC:67877-508-33 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67877-508-38)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209222 12/24/2017
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-509
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 40 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
PROPYL GALLATE
BUTYLATED HYDROXYANISOLE
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
WATER
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code A027
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-509-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-509-90 90 TABLET in 1 BOTTLE None
3 NDC:67877-509-05 500 TABLET in 1 BOTTLE None
4 NDC:67877-509-37 05 BLISTER PACK in 1 CARTON contains a BLISTER PACK (67877-509-33)
4 NDC:67877-509-33 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67877-509-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209222 12/24/2017
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67877-510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EZETIMIBE (EZETIMIBE) EZETIMIBE 10 mg
SIMVASTATIN (SIMVASTATIN) SIMVASTATIN 80 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
SODIUM LAURYL SULFATE
HYPROMELLOSE, UNSPECIFIED
ISOPROPYL ALCOHOL
PROPYL GALLATE
BUTYLATED HYDROXYANISOLE
MAGNESIUM STEARATE
CITRIC ACID MONOHYDRATE
WATER
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code A026
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67877-510-30 30 TABLET in 1 BOTTLE None
2 NDC:67877-510-90 90 TABLET in 1 BOTTLE None
3 NDC:67877-510-05 500 TABLET in 1 BOTTLE None
4 NDC:67877-510-37 05 BLISTER PACK in 1 CARTON contains a BLISTER PACK (67877-510-33)
4 NDC:67877-510-33 10 TABLET in 1 BLISTER PACK This package is contained within the CARTON (67877-510-37)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209222 12/24/2017
Labeler — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Alkem Laboratories Limited 677605851 ANALYSIS (67877-507), ANALYSIS (67877-508), ANALYSIS (67877-509), ANALYSIS (67877-510), MANUFACTURE (67877-507), MANUFACTURE (67877-508), MANUFACTURE (67877-509), MANUFACTURE (67877-510), PACK (67877-507), PACK (67877-508), PACK (67877-509), PACK (67877-510)

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.

https://medlibrary.org/lib/rx/meds/ezetimibe-and-simvastatin-4/page/11/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

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 © 2023. All Rights Reserved.