NDC Code(s) : 76237-304-30, 76237-304-39, 76237-307-30, 76237-307-39, 76237-309-30, 76237-309-39, 76237-312-30, 76237-312-39, 76237-314-30, 76237-314-39
Packager : Mckesson Contract Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lisinopril 2.5mgLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76237-304(NDC:0185-0025)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL2.5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 8 mm
Flavor Imprint Code E25
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76237-304-306 in 1 BOX, UNIT-DOSE
15 in 1 BLISTER PACK
2NDC:76237-304-3925 in 1 BOX
230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075994 08/01/2013
Lisinopril 5mgLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76237-307(NDC:0185-5400)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL5 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 8 mm
Flavor Imprint Code E54
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76237-307-306 in 1 BOX, UNIT-DOSE
15 in 1 BLISTER PACK
2NDC:76237-307-3925 in 1 BOX
230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075994 08/01/2013
Lisinopril 10mgLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76237-309(NDC:0185-0101)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code E101
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76237-309-306 in 1 BOX, UNIT-DOSE
15 in 1 BLISTER PACK
2NDC:76237-309-3925 in 1 BOX
230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075994 08/01/2013
Lisinopril 20mgLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76237-312(NDC:0185-0102)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL20 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
STARCH, CORN(UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color ORANGE Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code E102
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76237-312-306 in 1 BOX, UNIT-DOSE
15 in 1 BLISTER PACK
2NDC:76237-312-3925 in 1 BOX
230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075994 08/01/2013
Lisinopril 40mgLisinopril TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76237-314(NDC:0185-0104)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LISINOPRIL(UNII: E7199S1YWR)
(LISINOPRIL ANHYDROUS - UNII:7Q3P4BS2FD) 		LISINOPRIL40 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE(UNII: 97Z1WI3NDX)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
STARCH, CORN(UNII: O8232NY3SJ)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 10 mm
Flavor Imprint Code E104
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76237-314-306 in 1 BOX, UNIT-DOSE
15 in 1 BLISTER PACK
2NDC:76237-314-3925 in 1 BOX
230 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075994 08/01/2013

PRINCIPAL DISPLAY PANEL

Lisinopril Tablets 2.5mg

NDC 76237-304-30

Lisinopril Tablets USP, 2.5 mg

Each tablet contains Lisinopril USP...... 2.5 mg

Warning: Keep out of reach of Children.

Store at 20°-25°C (68°-77°F)[See USP controlled room temperature]

Dispense in a tight, light- resistant container.

PROTECT FROM LIGHT AND MOISTURE.

PRINCIPAL DISPLAY PANEL

2.5mg PL

PRINCIPAL DISPLAY PANEL

Lisinopril Tablets 5mg

NDC 76237-307-30

Lisinopril Tablets USP, 5 mg

Each tablet contains Lisinopril USP...... 5 mg

Warning: Keep out of reach of Children.

Store at 20°-25°C (68°-77°F)[See USP controlled room temperature]

Dispense in a tight, light- resistant container.

PROTECT FROM LIGHT AND MOISTURE.

PRINCIPAL DISPLAY PANEL

5mg PL

PRINCIPAL DISPLAY PANEL

Lisinopril Tablets 10mg

NDC 76237-309-30

Lisinopril Tablets USP, 10 mg

Each tablet contains Lisinopril USP...... 10 mg

Warning: Keep out of reach of Children.

Store at 20°-25°C (68°-77°F)[See USP controlled room temperature]

Dispense in a tight, light- resistant container.

PROTECT FROM LIGHT AND MOISTURE.

PRINCIPAL DISPLAY PANEL

10mg PL

PRINCIPAL DISPLAY PANEL

Lisinopril Tablets 20mg

NDC 76237-312-30

Lisinopril Tablets USP, 20 mg

Each tablet contains Lisinopril USP...... 20 mg

Warning: Keep out of reach of Children.

Store at 20°-25°C (68°-77°F)[See USP controlled room temperature]

Dispense in a tight, light- resistant container.

PROTECT FROM LIGHT AND MOISTURE.

PRINCIPAL DISPLAY PANEL

20mg PL

PRINCIPAL DISPLAY PANEL

40mg label

NDC 76237-314-30

Lisinopril Tablets USP, 40 mg

Each tablet contains Lisinopril USP...... 40 mg

Warning: Keep out of reach of Children.

Store at 20°-25°C (68°-77°F)[See USP controlled room temperature]

Dispense in a tight, light- resistant container.

PROTECT FROM LIGHT AND MOISTURE.

PRINCIPAL DISPLAY PANEL

40mg PL