sp;
STARCH, CORN
WATER
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color PINK (peach) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code ZESTORETIC;141
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0141-11 100 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019888 03/24/2011
ZESTORETIC
lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL) LISINOPRIL 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
WATER
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color WHITE (white) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code ZESTORETIC;142
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0142-10 100 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019888 03/24/2011
ZESTORETIC
lisinopril and hydrochlorothiazide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0310-0145
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL (LISINOPRIL) LISINOPRIL 20 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
MAGNESIUM STEARATE
MANNITOL
STARCH, CORN
WATER
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
Product Characteristics
Color PINK (peach) Score no score
Shape ROUND (Biconvex) Size 8mm
Flavor Imprint Code ZESTORETIC;145
Contains
Packaging
# NDC Package Description Multilevel Packaging
1 0310-0145-11 100 TABLET In 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019888 03/24/2011
Labeler - AstraZeneca Pharmaceuticals LP (054743190)
Registrant - AstraZeneca PLC (230790719)
Establishment
Name Address ID/FEI Operations
AstraZeneca UK Limited 232784079 MANUFACTURE
Establishment
Name Address ID/FEI Operations
AstraZeneca Pharmaceuticals LP 054
