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Lisinopril

Lisinopril Tablets USP

Approved
Approval ID

033c20a9-c298-4185-a48f-0bf8a2ac918a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 19, 2012

Manufacturers
FDA

H.J. Harkins Company, Inc.

DUNS: 147681894

Products 1

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 Code52959-728
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification

INGREDIENTS (8)

LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT

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Lisinopril - FDA Drug Approval Details