Tribenzor
These highlights do not include all the information needed to use TRIBENZOR safely and effectively. See full prescribing information for TRIBENZOR. TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets, for oral use Initial U.S. Approval: 2010
Approved
Approval ID
2f56d0bc-236b-41a0-9fc0-21cdfea8d890
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0877
Application NumberNDA200175
Product Classification
M
Marketing Category
C73594
G
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0874
Application NumberNDA200175
Product Classification
M
Marketing Category
C73594
G
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
OLMESARTAN MEDOXOMILActive
Quantity: 20 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0878
Application NumberNDA200175
Product Classification
M
Marketing Category
C73594
G
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 10 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0875
Application NumberNDA200175
Product Classification
M
Marketing Category
C73594
G
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0876
Application NumberNDA200175
Product Classification
M
Marketing Category
C73594
G
Generic Name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2023
FDA Product Classification
INGREDIENTS (8)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
OLMESARTAN MEDOXOMILActive
Quantity: 40 mg in 1 1
Code: 6M97XTV3HD
Classification: ACTIB
AMLODIPINE BESYLATEActive
Quantity: 5 mg in 1 1
Code: 864V2Q084H
Classification: ACTIM
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB