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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4785
Application NumberANDA076007
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2009
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4637
Application NumberANDA076007
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2009
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
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4977
Application NumberANDA076007
Product Classification
M
Marketing Category
C73584
G
Generic Name
LISINOPRIL AND HYDROCHLOROTHIAZIDE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 4, 2009
FDA Product Classification
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