Tribenzor: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC 0713-0876-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/5 mg*/25 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 0713-0876-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/5 mg*/25 mg 30 Tablets Rx only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0713-0877-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/12.5 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 0713-0877-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/10 mg*/12.5 mg 30 Tablets Rx only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0713-0878-30

TRIBENZOR

(olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets

40 mg/10 mg*/25 mg

30 Tablets

PRINCIPAL DISPLAY PANEL NDC 0713-0878-30 TRIBENZOR (olmesartan medoxomil, amlodipine, hydrochlorothiazide) tablets 40 mg/10 mg*/25 mg 30 Tablets Rx only
(click image for full-size original)

TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0874
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 20 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color orange Score no score
Shape ROUND Size 8mm
Flavor Imprint Code C51
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0874-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 06/15/2022
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0875
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C53
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0875-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 06/15/2022
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0876
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 5 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape OVAL Size 15mm
Flavor Imprint Code C54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0876-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 06/15/2022
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0877
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 12.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color red Score no score
Shape ROUND Size 10mm
Flavor Imprint Code C55
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0877-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 06/15/2022
TRIBENZOR olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0713-0878
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OLMESARTAN MEDOXOMIL (OLMESARTAN) OLMESARTAN MEDOXOMIL 40 mg
AMLODIPINE BESYLATE (AMLODIPINE) AMLODIPINE 10 mg
HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) HYDROCHLOROTHIAZIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
MICROCRYSTALLINE CELLULOSE
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color red Score no score
Shape OVAL Size 15mm
Flavor Imprint Code C57
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0713-0878-30 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200175 06/15/2022
Labeler — Cosette Pharmaceuticals, Inc. (116918230)

Revised: 06/2022 Cosette Pharmaceuticals, Inc.

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