Home NDC 65597-116-90 Tribenzor
Product NDC 65597-116
Requested package NDC 65597-116-90
11-digit product format 655970116
Labeler code 65597
Product ID 65597-116_d38366c2-56f0-47d2-add1-f87c9f5d6f30
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil / amlodipine besylate / hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Daiichi Sankyo, Inc.
Application NDA200175
Marketing category NDA
Marketing start 2010-07-31
Marketing end 2024-06-30
Substance AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength 5 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 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N200175-001 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 N200175-002 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 N200175-003 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 N200175-004 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 N200175-005 TRIBENZOR AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 6 · 215 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 215 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMLODIPINE BESYLATE ACTIVE INGREDIENT 864V2Q084H TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 OLMESARTAN MEDOXOMIL ACTIVE INGREDIENT 6M97XTV3HD TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 AMLODIPINE ACTIVE MOIETY 1J444QC288 TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 OLMESARTAN ACTIVE MOIETY 8W1IQP3U10 TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIBENZOR (OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.] 12
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tribenzor OLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDE Cosette Pharmaceuticals, Inc. 2f56d0bc-236b-41a0-9fc0-21cdfea8d890 2023-07-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 200175 application number: NDA200175
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65597-116-90 65597011690 90 TABLET, FILM COATED in 1 BOTTLE (65597-116-90) 2010-07-31 2024-06-30 No No Current