ENALAPRIL MALEATE tablet

ENALAPRIL MALEATE by

Drug Labeling and Warnings

ENALAPRIL MALEATE by is a Prescription medication manufactured, distributed, or labeled by Amici Pharma, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 69292-540-01

Enalapril Malete Tablets, USP

2.5 mg

Rx Only

100 Tablets

NDC: 69292-540-10

Enalapril Malete Tablets, USP

2.5 mg

Rx Only

1000 Tablets

NDC: 69292-542-01

Enalapril Malete Tablets, USP

5 mg

Rx Only

100 Tablets

NDC: 69292-542-10

Enalapril Malete Tablets, USP

5 mg

Rx Only

1000 Tablets

NDC: 69292-544-01

Enalapril Malete Tablets, USP

10 mg

Rx Only

100 Tablets

NDC: 69292-544-10

Enalapril Malete Tablets, USP

10 mg

Rx Only

1000 Tablets

NDC: 69292-546-01

Enalapril Malete Tablets, USP

20 mg

Rx Only

100 Tablets

NDC: 69292-546-10

Enalapril Malete Tablets, USP

20 mg

Rx Only

1000 Tablets

INGREDIENTS AND APPEARANCE

ENALAPRIL MALEATE 
enalapril maleate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69292-540
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)	ENALAPRIL MALEATE	2.5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69292-540-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025
2	NDC: 69292-540-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075483	09/23/2025

ENALAPRIL MALEATE 
enalapril maleate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69292-542
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)	ENALAPRIL MALEATE	5 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69292-542-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025
2	NDC: 69292-542-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075483	09/23/2025

ENALAPRIL MALEATE 
enalapril maleate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69292-544
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)	ENALAPRIL MALEATE	10 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE RED (UNII: 1K09F3G675)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69292-544-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025
2	NDC: 69292-544-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075483	09/23/2025

ENALAPRIL MALEATE 
enalapril maleate tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69292-546
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ENALAPRIL MALEATE (UNII: 9O25354EPJ) (ENALAPRILAT ANHYDROUS - UNII:Q508Q118JM)	ENALAPRIL MALEATE	20 mg

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
BROWN IRON OXIDE (UNII: 1N032N7MFO)

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	Marketing Start Date	Marketing End Date
1	NDC: 69292-546-10	1000 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025
2	NDC: 69292-546-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	09/23/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075483	09/23/2025

Labeler - Amici Pharma, Inc (119294414)