Lisinopril
These highlights do not include all the information needed to use LISINOPRIL TABLETS safely and effectively. See full prescribing information for LISINOPRIL TABLETSLISINOPRIL Tablets, for oral useInitial U.S. Approval: 1988
Approved
Approval ID
70ffae5e-ca7f-4ba2-be11-2d50fc9450ad
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 2015
Manufacturers
FDA
Ranbaxy Pharmaceuticals Inc.
DUNS: 937890044
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 Code63304-535
Application NumberANDA075944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2015
FDA Product Classification
INGREDIENTS (6)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-534
Application NumberANDA075944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2015
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-599
Application NumberANDA075944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2015
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 30 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-532
Application NumberANDA075944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2015
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-533
Application NumberANDA075944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2015
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63304-531
Application NumberANDA075944
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 5, 2015
FDA Product Classification
INGREDIENTS (6)
LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT