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LISINOPRIL

These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETS LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988

Approved
Approval ID

4aad4d30-3e18-489c-80ad-ccf7532bb933

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 19, 2023

Manufacturers
FDA

Exelan Pharmaceuticals, Inc

DUNS: 967795266

Products 6

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

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76282-728
Application NumberANDA076102
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (2)

LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76282-732
Application NumberANDA076102
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (3)

FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LISINOPRILActive
Quantity: 30 mg in 1 1
Code: E7199S1YWR
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76282-730
Application NumberANDA076102
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (3)

LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76282-729
Application NumberANDA076102
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (3)

LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76282-731
Application NumberANDA076102
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (3)

LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT

LISINOPRIL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76282-733
Application NumberANDA076102
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2023
FDA Product Classification

INGREDIENTS (3)

LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT

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LISINOPRIL - FDA Drug Approval Details