LISINOPRIL
These highlights do not include all the information needed to use LISINOPRIL safely and effectively. See full prescribing information for LISINOPRIL LISINOPRIL tablets, for oral use Initial U.S. Approval: 1988
Approved
Approval ID
052468a2-56df-4641-a343-3733f3ebe66e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 27, 2017
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-0376
Application NumberANDA202554
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2016
FDA Product Classification
INGREDIENTS (6)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB