Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide

Product NDC: 57664-796
11-digit product format: 576640796
Labeler code: 57664
Product ID: 57664-796_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: 2024-07-31
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-796		D	Discontinued by firm	2026-09-14
excluded package	package	57664-796	57664-796-83	D	Discontinued by firm	2026-09-14
excluded package	package	57664-796	57664-796-99	D	Discontinued by firm	2026-09-14

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 · 33 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-796-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-796-83	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-796-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-796-83	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-796-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-796-83	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-796-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-796-83	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-796-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-796-83	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-796-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-796-83	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-796-99	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-796-83	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-796-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-796-83	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-796-99	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-796-83	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-796-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-796-83	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-796-99	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-796-83	`367a005e9d99…`	`383a685ebd0f…`

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.

Application-product, TE code table
Application-product	TE code
N200175-001	AB
N200175-002	AB
N200175-003	AB
N200175-004	AB
N200175-005	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N200175-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N200175-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N200175-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N200175-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200175-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200175-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200175-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200175-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200175-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200175-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200175-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200175-005	AB	1	`03ed91905a0d…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fa898d56-9495-d6f0-309b-68a5d8e3914a	Product name	4	20260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
1199f4b7-b537-466c-9a1c-cb09131e9f8b	Product name	1	20251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6f	Product name	3	20251027
b15e9aa6-d523-ca97-480e-570e0543a342	Product name	4	20251024
265792b3-b999-c010-7364-a7db20b9d4d9	Product name	5	20250515
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
14c2c15b-f823-4ada-a40e-a440544294dc	Product name	1	20221207
162cbc9d-ecc3-72ba-af9f-c76e2756ef54	Product name	3	20221207
9b303cd4-3186-2454-5706-3137e8b2dfd2	Product name	4	20221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0ea	Product name	1	20200505
a72887ef-d675-499f-af4b-78688f6855cd	Product name	1	20191002
a8e65197-7914-7acf-c7ec-914d53819b34	Product name	3	20190624
8b67f333-47d1-8464-7ce4-406d3dbb295f	Product name	7	20190618
89a57420-ab44-5323-14f9-595159145f9b	Product name	2	20190612
c27b049d-3258-48cf-ebe5-08c236ae78e2	Product name	3	20190610
a4484670-2869-6416-f6ff-03b1b3cbd1b0	Product name	2	20190415
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
18600d07-613d-bf9c-2711-fe40c06f3393	Product name	5	20180703
00fc2cf9-672f-3e0b-6afa-43cbc864d058	Product name	4	20180613
15b375b1-89c7-9594-80df-5a8c8864aee0	Product name	3	20180108
a7349398-661d-d9fc-46df-7e128bbd61d9	Product name	5	20171113
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55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1	Product name	1	20150316
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041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
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DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-796-83	EA - Each	57664-796	8b5f9d5b-9be9-4f35-aed8-83d3a7585417	1	2016-11-08
57664-796-99	EA - Each	57664-796	e9439561-4820-4399-9b7d-1fd1a827314f	1	2016-11-08

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
0J48LPH2TH	HYDROCHLOROTHIAZIDE	58-93-5	HYDROCHLOROTHIAZIDE
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
999967	olmesartan medoxomil 20 MG / amLODIPine 5 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	852df50b-14bb-408f-b9c2-2cb708d24d76	1
999967	amlodipine 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SCD	852df50b-14bb-408f-b9c2-2cb708d24d76	1
999967	amlodipine (as amlodipine besylate) 5 MG / hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SY	852df50b-14bb-408f-b9c2-2cb708d24d76	1
999967	Amlodipine 5 MG / HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet	SY	852df50b-14bb-408f-b9c2-2cb708d24d76	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57664-796-83	57664079683	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-796-83)	2016-10-26	0000-00-00	No	No	Current
57664-796-99	57664079699	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-796-99)	2016-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	Sun Pharmaceutical Industries, Inc.	2022-07-13	HUMAN PRESCRIPTION DRUG LABEL	13
Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide	DOH CENTRAL PHARMACY	2019-01-21	HUMAN PRESCRIPTION DRUG LABEL	1