Vasotec (Page 6 of 6)

HOW SUPPLIED

VASOTEC (enalapril maleate) Tablets

NDC

Strength

Quantity

Description

0187-0140-30

2.5 mg

Bottles of 30 (with desiccant)

White, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other.

0187-0140-90

Bottles of 90 (with desiccant)

0187-0141-30

5 mg

Bottles of 30 (with desiccant)

White, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other.

0187-0141-90

Bottles of 90 (with desiccant)

0187-0142-30

10 mg

Bottles of 30 (with desiccant)

Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other.

0187-0142-90

Bottles of 90 (with desiccant)

0187-0142-10

Bottles of 1,000 (with desiccant)

0187-0143-30

20 mg

Bottles of 30 (with desiccant)

Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other.

0187-0143-90

Bottles of 90 (with desiccant)

0187-0143-10

Bottles of 1,000 (with desiccant)

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Keep container tightly closed.

Protect from moisture.

Dispense in a tight container as per USP, if product package is subdivided.

Distributed by:
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Steinbach, MB R5G 1Z7, Canada

VASOTEC is a trademark of Bausch Health Companies Inc. or its affiliates.

© 2020 Bausch Health Companies Inc. or its affiliates

9383005
20003089

Rev. 12/2020

PRINCIPAL DISPLAY PANEL — 2.5 mg Bottle Label

NDC 0187-0140-30

Rx Only

Vasotec ®
(enalapril maleate)Tablets

2.5 mg

30 Tablets

BAUSCH Health

2.5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 5 mg Bottle Label

NDC 0187-0141-30

Rx only

Vasotec ®
(enalapril maleate)Tablets

5 mg

30 Tablets

BAUSCH Health

5mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Bottle Label

NDC 0187-0142-30

Vasotec ®
(enalapril maleate)Tablets

10 mg

30 Tablets

BAUSCH Health

10mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Bottle Label

NDC 0187-0143-30

Rx only

Vasotec ®
(enalapril maleate)Tablets

20 mg

30 Tablets

BAUSCH Health

20mg
(click image for full-size original)
VASOTEC enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0140
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
magnesium stearate
sodium stearate
sodium bicarbonate
starch, corn
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 6mm
Flavor Imprint Code VASO;2;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0140-30 30 TABLET in 1 BOTTLE None
2 NDC:0187-0140-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018998 07/26/1988
VASOTEC enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0141
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
magnesium stearate
sodium stearate
sodium bicarbonate
starch, corn
Product Characteristics
Color WHITE Score 2 pieces
Shape TRIANGLE (rounded triangle) Size 8mm
Flavor Imprint Code VASO;5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0141-30 30 TABLET in 1 BOTTLE None
2 NDC:0187-0141-90 90 TABLET in 1 BOTTLE None
3 NDC:0187-0141-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018998 12/24/1985
VASOTEC enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0142
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
magnesium stearate
sodium stearate
sodium bicarbonate
starch, corn
ferric oxide red
Product Characteristics
Color RED (Rust red color) Score 2 pieces
Shape TRIANGLE (rounded triangle) Size 8mm
Flavor Imprint Code VASO;10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0142-30 30 TABLET in 1 BOTTLE None
2 NDC:0187-0142-90 90 TABLET in 1 BOTTLE None
3 NDC:0187-0142-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018998 12/24/1985
VASOTEC enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0187-0143
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Enalapril Maleate (Enalaprilat Anhydrous) Enalapril Maleate 20 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
magnesium stearate
sodium stearate
sodium bicarbonate
starch, corn
ferric oxide red
ferric oxide yellow
Product Characteristics
Color PINK (Pink Peach color) Score 2 pieces
Shape TRIANGLE (rounded triangle) Size 8mm
Flavor Imprint Code VASO;20
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0187-0143-30 30 TABLET in 1 BOTTLE None
2 NDC:0187-0143-90 90 TABLET in 1 BOTTLE None
3 NDC:0187-0143-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018998 12/24/1985
Labeler — Bausch Health US LLC (831922468)
Establishment
Name Address ID/FEI Operations
Bausch Health Companies 253292734 MANUFACTURE (0187-0140), MANUFACTURE (0187-0141), MANUFACTURE (0187-0142), MANUFACTURE (0187-0143), PACK (0187-0140), PACK (0187-0141), PACK (0187-0142), PACK (0187-0143), LABEL (0187-0140), LABEL (0187-0141), LABEL (0187-0142), LABEL (0187-0143)

Revised: 12/2020 Bausch Health US LLC

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