Lisinopril
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
34ebeea1-6812-4697-84c4-b2ae4f39e55f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2021
Manufacturers
FDA
BluePoint Laboratories
DUNS: 985523874
Products 7
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 Code68001-486
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-335
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
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: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-332
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
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
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-333
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
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: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-337
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-334
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (7)
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68001-336
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2021
FDA Product Classification
INGREDIENTS (7)
LISINOPRILActive
Quantity: 30 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
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