LISINOPRIL AND HYDROCHLOROTHIAZIDE
Approved
Approval ID
4700340f-4f77-48f2-bef2-bf6391bc25da
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2009
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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
NDC Product Code54868-4785
Application NumberANDA076007
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 4, 2009
Generic NameLISINOPRIL AND HYDROCHLOROTHIAZIDE
INGREDIENTS (8)
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
LISINOPRIL AND HYDROCHLOROTHIAZIDE
PRODUCT DETAILS
NDC Product Code54868-4637
Application NumberANDA076007
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 4, 2009
Generic NameLISINOPRIL AND HYDROCHLOROTHIAZIDE
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
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LISINOPRIL AND HYDROCHLOROTHIAZIDE
PRODUCT DETAILS
NDC Product Code54868-4977
Application NumberANDA076007
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 4, 2009
Generic NameLISINOPRIL AND HYDROCHLOROTHIAZIDE
INGREDIENTS (7)
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT