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ENALAPRIL MALEATE

ENALAPRIL MALEATE TABLETS, USP

Approved
Approval ID

d5de9308-d491-4bb6-e053-2995a90a030c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 18, 2022

Manufacturers
FDA

NuCare Pharmaceuticals,Inc.

DUNS: 010632300

Products 1

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 Code68071-2618
Application NumberANDA075483
Product Classification
M
Marketing Category
C73584
G
Generic Name
ENALAPRIL MALEATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 18, 2022
FDA Product Classification

INGREDIENTS (7)

ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
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 MALEATEActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB

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ENALAPRIL MALEATE - FDA Drug Approval Details