Prescription Drug Information: ENALAPRIL MALEATE (Page 6 of 6)

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.

———————————————–

# Trademark of Paddock Laboratories, Inc.

Manufactured by:

Wockhardt Limited

H-14/2, M.I.D.C. Area, Waluj,

Aurangabad, Maharashtra,

India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Rev.041018

DRUG: ENALAPRIL MALEATE

GENERIC: ENALAPRIL MALEATE

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 70518-0028-0

COLOR: brown

SHAPE: ROUND

SCORE: No score

SIZE: 8 mm

IMPRINT: W;926

PACKAGING: 90 in 1 BOTTLE, PLASTIC

ACTIVE INGREDIENT(S):

  • ENALAPRIL MALEATE 20mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • STARCH, CORN
  • STEARIC ACID
  • BROWN IRON OXIDE
  • HYPROMELLOSE 2910 (6 MPA.S)
  • TALC
Remedy_Label
(click image for full-size original)
ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-0028(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:70518-0028-0 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075483 12/01/2016
Labeler — REMEDYREPACK INC. (829572556)

Revised: 02/2020 REMEDYREPACK INC.

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