ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLETS, USP

Approved

Approval ID

a88902bd-742f-4ea6-b625-cc9df1709efc

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 26, 2025

Manufacturers

FDA

Amici Pharma, Inc

DUNS: 119294414

Products 4

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

enalapril maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69292-546

Application NumberANDA075483

Product Classification

Marketing Category

C73584

Generic Name

enalapril maleate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 26, 2025

FDA Product Classification

INGREDIENTS (7)

ENALAPRIL MALEATEActive

Quantity: 20 mg in 1 1

Code: 9O25354EPJ

Classification: ACTIB

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

BROWN IRON OXIDEInactive

Code: 1N032N7MFO

Classification: IACT

enalapril maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69292-540

Application NumberANDA075483

Product Classification

Marketing Category

C73584

Generic Name

enalapril maleate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 26, 2025

FDA Product Classification

INGREDIENTS (6)

ENALAPRIL MALEATEActive

Quantity: 2.5 mg in 1 1

Code: 9O25354EPJ

Classification: ACTIB

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

enalapril maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69292-542

Application NumberANDA075483

Product Classification

Marketing Category

C73584

Generic Name

enalapril maleate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 26, 2025

FDA Product Classification

INGREDIENTS (6)

ENALAPRIL MALEATEActive

Quantity: 5 mg in 1 1

Code: 9O25354EPJ

Classification: ACTIB

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

enalapril maleate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code69292-544

Application NumberANDA075483

Product Classification

Marketing Category

C73584

Generic Name

enalapril maleate

Product Specifications

Route of AdministrationORAL

Effective DateSeptember 26, 2025

FDA Product Classification

INGREDIENTS (7)

ENALAPRIL MALEATEActive

Quantity: 10 mg in 1 1

Code: 9O25354EPJ

Classification: ACTIB

ANHYDROUS LACTOSEInactive

Code: 3SY5LH9PMK

Classification: IACT

HYPROMELLOSE 2910 (6 MPA.S)Inactive

Code: 0WZ8WG20P6

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65AP

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

Drug Labeling Information