Zestril
These highlights do not include all the information needed to use ZESTRIL safely and effectively. See full prescribing information for ZESTRIL ZESTRIL(lisinopril) tablets, for oral use Initial U.S. Approval: 1988
Approved
Approval ID
838c2d78-d2d8-4981-9ec9-e50ef9e1a5d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2025
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code24979-243
Application NumberNDA019777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2025
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-239
Application NumberNDA019777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2025
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-242
Application NumberNDA019777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2025
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 30 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-238
Application NumberNDA019777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2025
FDA Product Classification
INGREDIENTS (5)
LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-240
Application NumberNDA019777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2025
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24979-241
Application NumberNDA019777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2025
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT