Lisinopril and hydrochlorothiazide
Lisinopril and Hydrochlorothiazide TabletsRevised: March 2009Rx only 184007
Approved
Approval ID
63fa5147-fb3e-47ec-bea1-a80e1f551866
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-734
Application NumberANDA076194
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2010
FDA Product Classification
INGREDIENTS (8)
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
Lisinopril and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-735
Application NumberANDA076194
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2010
FDA Product Classification
INGREDIENTS (8)
LISINOPRILActive
Quantity: 20 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Lisinopril and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-733
Application NumberANDA076194
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lisinopril and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2010
FDA Product Classification
INGREDIENTS (8)
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LISINOPRILActive
Quantity: 10 mg in 1 1
Code: E7199S1YWR
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT