NDC Code(s) : 51079-951-01, 51079-951-20, 51079-952-01, 51079-952-20, 51079-953-01, 51079-953-20, 51079-950-01, 51079-950-20
Packager : Mylan Institutional Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Enalapril MaleateEnalapril Maleate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-951(NDC:0378-1052)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE(UNII: 9O25354EPJ)
(ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM) 		ENALAPRIL MALEATE5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALEIC ACID(UNII: 91XW058U2C)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code M;E16
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-951-20100 in 1 CARTON 15/11/2000
1NDC:51079-951-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000
Enalapril MaleateEnalapril Maleate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-952(NDC:0378-1053)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE(UNII: 9O25354EPJ)
(ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM) 		ENALAPRIL MALEATE10 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALEIC ACID(UNII: 91XW058U2C)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (light blue) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code M;E17
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-952-20100 in 1 CARTON 15/11/2000
1NDC:51079-952-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000
Enalapril MaleateEnalapril Maleate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-953(NDC:0378-1054)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE(UNII: 9O25354EPJ)
(ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM) 		ENALAPRIL MALEATE20 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALEIC ACID(UNII: 91XW058U2C)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (medium blue) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code M;E18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-953-20100 in 1 CARTON 15/11/2000
1NDC:51079-953-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000
Enalapril Maleateenalapril maleate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51079-950(NDC:0378-1051)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENALAPRIL MALEATE(UNII: 9O25354EPJ)
(ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM) 		ENALAPRIL MALEATE2.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALEIC ACID(UNII: 91XW058U2C)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
Product Characteristics
Color white Score 2 pieces
Shape ROUND Size 6 mm
Flavor Imprint Code M;E15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:51079-950-20100 in 1 CARTON 15/11/2000
1NDC:51079-950-011 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/15/2000

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 2.5 mg

NDC 51079-950-20

Enalapril
Maleate
Tablets, USP
2.5 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 2.5 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-7557 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 2.5 mg Tablets Unit Carton LabelEnalapril Maleate 2.5 mg Tablets Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 5 mg

NDC 51079-951-20

Enalapril
Maleate
Tablets, USP
5 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 5 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-7558 R4

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 5 mg Tablets Unit Carton LabelEnalapril Maleate 5 mg Tablets Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 10 mg

NDC 51079-952-20

Enalapril
Maleate
Tablets, USP
10 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 10 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-7559 R5

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 10 mg Tablets Unit Carton LabelEnalapril Maleate 10 mg Tablets Unit Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 20 mg

NDC 51079-953-20

Enalapril
Maleate
Tablets, USP
20 mg

100 Tablets (10 x 10)

Each tablet contains:
Enalapril maleate, USP . . . . 20 mg

Usual Dosage: See accompanying
prescribing information.

Store at 20° to 25°C (68° to 77°F).
[See USP Controlled Room Temperature.]
Protect from moisture.

Manufactured by:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Rx only

S-7560 R3

Packaged and Distributed by:

Mylan Institutional Inc.

Rockford, IL 61103 U.S.A.

This unit dose package is not child resistant.

For institutional use only.

Keep this and all drugs out of the reach of children.

This container provides light-resistance.

See window for lot number and expiration date.

Enalapril Maleate 20 mg Tablets Unit Carton LabelEnalapril Maleate 20 mg Tablets Unit Carton Label