Lisinopril
Lisinopril Tablets USP
Approved
Approval ID
d87620e1-1a43-43a2-ab37-b9111ea5c17e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 3
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 Code63187-257
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (7)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-237
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (7)
LISINOPRILActive
Quantity: 40 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
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-098
Application NumberANDA077321
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2018
FDA Product Classification
INGREDIENTS (7)
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
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
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT