Ezetimibe and Simvastatin (Page 11 of 11)

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EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1155
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
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PROPYL GALLATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code AA70
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1155-3 30 TABLET in 1 BOTTLE None
2 NDC:69238-1155-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208831 11/21/2017
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1156
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
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PROPYL GALLATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code AA71
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1156-3 30 TABLET in 1 BOTTLE None
2 NDC:69238-1156-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208831 11/21/2017
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1157
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
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PROPYL GALLATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code AA72
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1157-3 30 TABLET in 1 BOTTLE None
2 NDC:69238-1157-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208831 11/21/2017
EZETIMIBE AND SIMVASTATIN ezetimibe and simvastatin tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1158
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
BUTYLATED HYDROXYANISOLE
CITRIC ACID MONOHYDRATE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
PROPYL GALLATE
Product Characteristics
Color WHITE (white to off white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code AA73
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1158-3 30 TABLET in 1 BOTTLE None
2 NDC:69238-1158-9 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208831 11/21/2017
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals Private Limited Oral Solid Dosage Unit 650762060 MANUFACTURE (69238-1155), MANUFACTURE (69238-1156), MANUFACTURE (69238-1157), MANUFACTURE (69238-1158), PACK (69238-1155), PACK (69238-1156), PACK (69238-1157), PACK (69238-1158)

Revised: 01/2021 Amneal Pharmaceuticals NY LLC

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