Products5
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tribenzor
Product Details
NDC Product Code
0713-0877Application Number
NDA200175Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 12, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 10 mg in 1 1
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
OlmesartanActive
Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
Tribenzor
Product Details
NDC Product Code
0713-0874Application Number
NDA200175Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 12, 2023MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 5 mg in 1 1
OlmesartanActive
Code: 6M97XTV3HDClass: ACTIBQuantity: 20 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
Tribenzor
Product Details
NDC Product Code
0713-0878Application Number
NDA200175Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 12, 2023CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
OlmesartanActive
Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 10 mg in 1 1
Tribenzor
Product Details
NDC Product Code
0713-0875Application Number
NDA200175Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 12, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
OlmesartanActive
Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 12.5 mg in 1 1
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 5 mg in 1 1
Tribenzor
Product Details
NDC Product Code
0713-0876Application Number
NDA200175Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
July 12, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
OlmesartanActive
Code: 6M97XTV3HDClass: ACTIBQuantity: 40 mg in 1 1
AmlodipineActive
Code: 864V2Q084HClass: ACTIMQuantity: 5 mg in 1 1
HydrochlorothiazideActive
Code: 0J48LPH2THClass: ACTIBQuantity: 25 mg in 1 1