ENALAPRIL MALEATE (Page 6 of 6)

HOW SUPLLIED

Enalapril Maleate Tablets, USP
NDC number	Strength	Description	Quantity
NDC 68645-455-90	5 mg	White, round flat-faced beveled edged, compressed tablets with W on one side and breakline on the other side. 924	Bottles of 90
NDC 68645-456-90	10 mg	Light Salmon, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side. 925	Bottles of 90
NDC 68645-457-90	20 mg	Light Beige, round flat-faced beveled edged, compressed tablets with W on one side plain on the other side. 926	Bottles of 90

Storage

Store below 25°C (77°F), excursion permitted to 15-30°C (59-86°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.

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^# Trademark of Paddock Laboratories, Inc.

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Distributed by:

Wal-Mart

Bentonville, AR 72716

Packaged by:

Legacy Pharmaceutical Packaging, LLC

13333 Lakefront Drive

Rev.041018

ENALAPRIL MALEATE TABLETS, USP 2.5MG

ENALAPRIL MALEATE TABLETS, USP 5MG

ENALAPRIL MALEATE TABLETS, USP 10MG

ENALAPRIL MALEATE TABLETS, USP 20MG

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-454(NDC:64679-923) 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 ANHYDROUS LACTOSE HYPROMELLOSE 2910 (6 MPA.S) STARCH, CORN STEARIC ACID TALC

Product Characteristics Color white (White) Score 2 pieces Shape ROUND (round flat-faced beveled edged) Size 6mm Flavor Imprint Code W;923 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68645-454-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075483 12/11/2009 03/31/2017

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-455(NDC:64679-924) 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 ANHYDROUS LACTOSE HYPROMELLOSE 2910 (6 MPA.S) STARCH, CORN STEARIC ACID TALC

Product Characteristics Color white (White) Score 2 pieces Shape ROUND (round flat-faced beveled edged) Size 8mm Flavor Imprint Code W;924 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68645-455-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075483 12/11/2009

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-456(NDC:64679-925) 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 ANHYDROUS LACTOSE FERRIC OXIDE RED HYPROMELLOSE 2910 (6 MPA.S) STARCH, CORN STEARIC ACID TALC

Product Characteristics Color orange (Light Salmon) Score no score Shape ROUND (round flat-faced beveled edged) Size 8mm Flavor Imprint Code W;925 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68645-456-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075483 12/11/2009

ENALAPRIL MALEATE enalapril maleate tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68645-457(NDC:64679-926) 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 ANHYDROUS LACTOSE BROWN IRON OXIDE HYPROMELLOSE 2910 (6 MPA.S) STARCH, CORN STEARIC ACID TALC

Product Characteristics Color brown (Light Beige) Score no score Shape ROUND (round flat-faced beveled edged) Size 8mm Flavor Imprint Code W;926 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:68645-457-90 90 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075483 12/11/2009

Labeler — Legacy Pharmaceutical Packaging, LLC (143213275)

Revised: 12/2020 Legacy Pharmaceutical Packaging, LLC