FDA.reportPublic FDA data

Tribenzor

Product NDC
0713-0874
11-digit product format
007130874
Labeler code
0713
Product ID
0713-0874_004953ba-fe11-03eb-e063-6394a90a638c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA200175
Marketing category
NDA
Marketing start
2022-09-01
Substance
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength
5; 12.5; 20 mg/1; mg/1; mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tribenzor
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE5 mg/1
HYDROCHLOROTHIAZIDE12.5 mg/1
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD, 864V2Q084H, 0J48LPH2TH
Rxcui999967, 999971, 999986, 999990, 999991, 999995, 999996, 1000000, 1000001, 1000005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0713-0874-30Tribenzor30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0874TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20230713_2f56d0bc-236b-41a0-9fc0-21cdfea8d890.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999967olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991olmesartan medoxomil 40 MG / amLODIPine 10 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001olmesartan medoxomil 40 MG / amLODIPine 5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971TRIBENZOR 20 MG / 5 MG / 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990TRIBENZOR 40 MG / 10 MG / 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995TRIBENZOR 40 MG / 10 MG / 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000TRIBENZOR 40 MG / 5 MG / 12.5 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005TRIBENZOR 40 MG / 5 MG / 25 MG Oral TabletPSN2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SBD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986amlodipine 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991amlodipine 10 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999967amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001amlodipine 5 MG / hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral TabletSCD2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991amlodipine (as amlodipine besilate) 10 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001amlodipine (as amlodipine besilate) 5 MG / HCTZ 25 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996amlodipine (as amlodipine besilate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986amlodipine (as amlodipine besylate) 10 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999967amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999986Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990Amlodipine 10 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999991Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995Amlodipine 10 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999967Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999996Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000001Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005Amlodipine 5 MG / HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Tribenzor]SY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999971Tribenzor 20/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999990Tribenzor 40/10/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
999995Tribenzor 40/10/25 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000000Tribenzor 40/5/12.5 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903
1000005Tribenzor 40/5/25 (olmesartan medoxomil / amlodipine (as amlodipine besylate) / HCTZ) Oral TabletSY2f56d0bc-236b-41a0-9fc0-21cdfea8d8903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0874-300071308743030 TABLET, FILM COATED in 1 BOTTLE (0713-0874-30) 2022-09-010000-00-00NoNoCurrent