Home NDC 65597-116-30 Tribenzor
Product NDC 65597-116
Requested package NDC 65597-116-30
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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.
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 2026-08-01 22:54:32 2026-06 N200175-001 TRIBENZOR EQ 5MG BASE;12.5MG;20MG TABLET / ORAL AB RLD 2010-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N200175-002 TRIBENZOR EQ 5MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N200175-003 TRIBENZOR EQ 5MG BASE;25MG;40MG TABLET / ORAL AB RLD 2010-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N200175-004 TRIBENZOR EQ 10MG BASE;12.5MG;40MG TABLET / ORAL AB RLD 2010-07-23 a50c72e98297…2026-08-01 22:54:32 2026-06 N200175-005 TRIBENZOR EQ 10MG BASE;25MG;40MG TABLET / ORAL AB RLD, RS 2010-07-23 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 65597-116-30 65597011630 30 TABLET, FILM COATED in 1 BOTTLE (65597-116-30) 2010-07-31 2024-06-30 No No Current