lisinopril
These highlights do not include all the information needed to use LISINOPRIL TABLETSsafely and effectively. See full prescribing information for LISINOPRIL TABLETSLISINOPRIL tablets, for oral useInitial U.S. Approval: 1988
Approved
Approval ID
1bc69836-a659-4e3b-84a7-a00b7c4dc268
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2020
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 Code76282-421
Application NumberANDA203508
Product Classification
M
Marketing Category
C73584
G
Generic Name
lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LISINOPRILActive
Quantity: 30 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-420
Application NumberANDA203508
Product Classification
M
Marketing Category
C73584
G
Generic Name
lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-422
Application NumberANDA203508
Product Classification
M
Marketing Category
C73584
G
Generic Name
lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-419
Application NumberANDA203508
Product Classification
M
Marketing Category
C73584
G
Generic Name
lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-417
Application NumberANDA203508
Product Classification
M
Marketing Category
C73584
G
Generic Name
lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (5)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-418
Application NumberANDA203508
Product Classification
M
Marketing Category
C73584
G
Generic Name
lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2020
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT