NDC Code(s) : 52125-336-02, 52125-336-19
Packager : REMEDYREPACK 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:52125-336(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
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALEIC ACID(UNII: 91XW058U2C)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
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:52125-336-0230 in 1 BLISTER PACK Type 0: Not a Combination Product29/11/2012
2NDC:52125-336-1990 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/11/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075480 11/29/2012

PRINCIPAL DISPLAY PANEL

DRUG: Enalapril Maleate

GENERIC: Enalapril Maleate

DOSAGE: TABLET

ADMINSTRATION: ORAL

NDC: 52125-336-02

NDC: 52125-336-19

COLOR: white

SHAPE: ROUND

SCORE: Two even pieces

SIZE: 8 mm

IMPRINT: M;E16

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 90 in 1 BOTTLE PLASTIC

ACTIVE INGREDIENT(S):

  • ENALAPRIL MALEATE 5mg in 1

INACTIVE INGREDIENT(S):

  • ANHYDROUS LACTOSE
  • CELLULOSE, MICROCRYSTALLINE
  • STARCH, CORN
  • MALEIC ACID
  • MAGNESIUM STEARATE
  • SILICON DIOXIDE
  • SODIUM LAURYL SULFATE MM2
  • MM2