Lisinopril and Hydrochlorothiazide
LISINOPRIL AND HYDROCHLOROTHIAZIDE- hydrochlorothiazide and lisinopril tablet LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS USP
Approved
Approval ID
6414f16f-c3e0-4ca1-ad58-ed081a9c0b09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lisinopril and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-993
Application NumberANDA077912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (8)
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
Lisinopril and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-992
Application NumberANDA077912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (7)
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
Lisinopril and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-991
Application NumberANDA077912
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2019
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT