Home NDC 57664-797-99 Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide
Product NDC 57664-797
Requested package NDC 57664-797-99
11-digit product format 576640797
Labeler code 57664
Product ID 57664-797_e97e6623-9454-4d2f-8cbc-d84db5f0b5ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Application NDA200175
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-10-26
Marketing end 2024-04-30
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 57664-797-99 57664079799 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-797-99) 2016-10-26 2024-04-30 No No Current