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Lisinopril

LISINOPRIL TABLETS. 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

fab269ea-9513-3702-e053-6394a90ada0d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 1, 2023

Manufacturers
FDA

Pharmasource Meds, LLC

DUNS: 118772692

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 Code82982-066
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2023
FDA Product Classification

INGREDIENTS (7)

ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
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
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB

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Lisinopril - FDA Drug Approval Details