Lisinopril
LISINOPRIL TABLETS, USP
Approved
Approval ID
c7e7d939-8f5c-4443-b6cf-c306e06ddf67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 6, 2010
Manufacturers
FDA
Med-Health Pharma, LLC
DUNS: 962603812
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 Code51138-067
Application NumberANDA076063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (8)
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LISINOPRILActive
Quantity: 30 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-068
Application NumberANDA076063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (8)
LISINOPRILActive
Quantity: 40 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-066
Application NumberANDA076063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-063
Application NumberANDA076063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LISINOPRILActive
Quantity: 2.5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-065
Application NumberANDA076063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
Lisinopril
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51138-064
Application NumberANDA076063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril
Product Specifications
Route of AdministrationORAL
Effective DateJuly 6, 2010
FDA Product Classification
INGREDIENTS (8)
LISINOPRILActive
Quantity: 5 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT