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Enalapril Maleate

Enalapril Maleate Tablets, USP

Approved
Approval ID

7df3210d-7a75-4936-96d6-ece76bb06da9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 22, 2023

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

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 Code68788-7967
Application NumberANDA075657
Product Classification
M
Marketing Category
C73584
G
Generic Name
Enalapril Maleate
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2023
FDA Product Classification

INGREDIENTS (5)

Enalapril MaleateActive
Quantity: 10 mg in 1 1
Code: 9O25354EPJ
Classification: ACTIB
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium BicarbonateInactive
Code: 8MDF5V39QO
Classification: IACT
Ferric Oxide RedInactive
Code: 1K09F3G675
Classification: IACT

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 5/22/2023

HOW SUPPLIED

Enalapril Maleate Tablets USP, 10 mg are white colored, round, biconvex tablets. One side scored and engraved with "T" above the score and with "10" under the score. The other side plain. They are supplied as follows:

NDC 68788-7967-3 in bottles of 30 Tablets

**NDC** 68788-7967-6 in bottles of 60 Tablets
**NDC** 68788-7967-9 in bottles of 90 Tablets
**NDC** 68788-7967-1 in bottles of 100 Tablets

Storage

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Keep container tightly closed.

Protect from moisture.

Dispense in a tight container as per USP, if product package is subdivided.

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