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

ENALAPRIL MALEATE

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ENALAPRIL MALEATE

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ENALAPRIL MALEATE enalapril maleate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0689(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:50090-0689-1 100 TABLET in 1 BOTTLE None
2 NDC:50090-0689-0 30 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:50090-0690(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:50090-0690-1 100 TABLET in 1 BOTTLE None
2 NDC:50090-0690-2 60 TABLET in 1 BOTTLE None
3 NDC:50090-0690-4 90 TABLET in 1 BOTTLE None
4 NDC:50090-0690-0 30 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:50090-0692(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:50090-0692-1 60 TABLET in 1 BOTTLE None
2 NDC:50090-0692-3 90 TABLET in 1 BOTTLE None
3 NDC:50090-0692-0 30 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 — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0689), REPACK (50090-0689), RELABEL (50090-0690), REPACK (50090-0690), RELABEL (50090-0692), REPACK (50090-0692)

Revised: 06/2022 A-S Medication Solutions

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