Enalapril Maleate (Page 6 of 6)

HOW SUPPLIED

Enalapril Maleate Tablets
NDC	Strength	Quantity	Description
68682-710-01 68682-710-10	2.5 mg	Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant)	White, oval shaped tablet imprinted with “VASO 2.5” and scored on one side and scored on the other.
68682-711-01 68682-711-10	5 mg	Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant)	White, rounded triangle shaped tablet imprinted with “VASO 5” on one side and scored on the other.
68682-712-01 68682-712-10	10 mg	Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant)	Rust red, rounded triangle shaped tablet imprinted with “VASO 10” on one side and scored on the other.
68682-713-01 68682-713-10	20 mg	Bottles of 100 (with desiccant) Bottles of 1,000 (with desiccant)	Peach, rounded triangle shaped tablet imprinted with “VASO 20” on one side and scored on the other.

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:

Oceanside Pharmaceuticals, a division of

Bausch Health US, LLC

Bridgewater, NJ 08807 USA

Manufactured by:

Bausch Health Companies Inc.

Steinbach, MB R5G 1Z7, Canada

© 2020 Bausch Health Companies Inc. or its affiliates

9450104_20003098

Rev. 12/2020

PRINCIPAL DISPLAY PANEL – 2. 5 mg

NDC 68682-710-01

Rx only

Enalapril Maleate Tablets

2.5 mg

100 Tablets

OCEANSIDE PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL – 5 mg

NDC 68682-711-01

Rx only

Enalapril Maleate Tablets

5 mg

100 Tablets

Oceanside Pharmaceuticals

PRINCIPAL DISPLAY PANEL – 10 mg

NDC 68682-712-01

Rx only

Enalapril Maleate Tablets

10 mg

100 Tablets

OCEANSIDE PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL – 20 mg

NDC 68682-713-01

Rx only

Enalapril Maleate Tablets

20 mg

100 Tablets

OCEANSIDE PHARMACEUTICALS

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-710 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:68682-710-30 30 TABLET in 1 BOTTLE None 2 NDC:68682-710-90 90 TABLET in 1 BOTTLE None 3 NDC:68682-710-01 100 TABLET in 1 BOTTLE None 4 NDC:68682-710-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018998 07/26/1988

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-711 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:68682-711-30 30 TABLET in 1 BOTTLE None 2 NDC:68682-711-90 90 TABLET in 1 BOTTLE None 3 NDC:68682-711-01 100 TABLET in 1 BOTTLE None 4 NDC:68682-711-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018998 12/24/1985

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-712 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:68682-712-30 30 TABLET in 1 BOTTLE None 2 NDC:68682-712-90 90 TABLET in 1 BOTTLE None 3 NDC:68682-712-01 100 TABLET in 1 BOTTLE None 4 NDC:68682-712-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018998 12/24/1985

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68682-713 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:68682-713-30 30 TABLET in 1 BOTTLE None 2 NDC:68682-713-90 90 TABLET in 1 BOTTLE None 3 NDC:68682-713-01 100 TABLET in 1 BOTTLE None 4 NDC:68682-713-10 1000 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA authorized generic NDA018998 12/24/1985

Labeler — OCEANSIDE PHARMACEUTICALS (832011691)

Registrant — VALEANT PHARMACEUTICALS NORTH AMERICA LLC (042230623)

Establishment
Name	Address	ID/FEI	Operations
Bausch Health Companies		253292734	MANUFACTURE (68682-710), MANUFACTURE (68682-711), MANUFACTURE (68682-712), MANUFACTURE (68682-713), PACK (68682-710), PACK (68682-711), PACK (68682-712), PACK (68682-713), LABEL (68682-710), LABEL (68682-711), LABEL (68682-712), LABEL (68682-713)

Establishment
Name	Address	ID/FEI	Operations
Carton Service Incorporated		928861723	LABEL (68682-710), LABEL (68682-711), LABEL (68682-712), LABEL (68682-713)

Revised: 12/2020 OCEANSIDE PHARMACEUTICALS