MedPath

LISINOPRIL

Approved
Approval ID

21e8592c-ea81-4604-b694-8e095b046593

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 8, 2011

Manufacturers
FDA

STAT RX USA LLC

DUNS: 786036330

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 Code16590-306
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL
Product Specifications
Route of AdministrationORAL
Effective DateJune 8, 2011
FDA Product Classification

INGREDIENTS (8)

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

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

LISINOPRIL - FDA Drug Approval Details