Benicar HCT

Product NDC: 65597-105
11-digit product format: 655970105
Labeler code: 65597
Product ID: 65597-105_95b56527-9a72-45dd-a7a5-378d72a1aba7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil-hydrochlorothiazide
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Daiichi Sankyo, Inc.
Application: NDA021532
Marketing category: NDA
Marketing start: 2003-06-05
Marketing end: 2023-09-30
Substance: HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
Active strength: 13 mg/1; mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	65597-105		D	Discontinued by firm	2026-09-09
excluded package	package	65597-105	65597-105-07	D	Discontinued by firm	2026-09-09
excluded package	package	65597-105	65597-105-11	D	Discontinued by firm	2026-09-09
excluded package	package	65597-105	65597-105-30	D	Discontinued by firm	2026-09-09
excluded package	package	65597-105	65597-105-90	D	Discontinued by firm	2026-09-09

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 · 60 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	65597-105-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65597-105-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65597-105-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	65597-105-11	`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	65597-105-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65597-105-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65597-105-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	65597-105-11	`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	65597-105-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65597-105-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65597-105-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	65597-105-11	`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	65597-105-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65597-105-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65597-105-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	65597-105-11	`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	65597-105-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65597-105-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65597-105-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	65597-105-11	`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	65597-105-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65597-105-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65597-105-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	65597-105-11	`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	65597-105-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65597-105-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65597-105-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	65597-105-11	`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	65597-105-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65597-105-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65597-105-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	65597-105-11	`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	65597-105-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65597-105-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65597-105-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	65597-105-11	`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	65597-105-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65597-105-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65597-105-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	65597-105-11	`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	65597-105-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65597-105-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65597-105-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	65597-105-11	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65597-105-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65597-105-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65597-105-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	65597-105-11	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021532-002	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05
N021532-003	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05
N021532-005	BENICAR HCT	HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021532-002	AB
N021532-003	AB
N021532-005	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 4 · 126 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
2026-08-18 06:07:40	2026-07	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-003	BENICAR HCT	12.5MG;40MG	TABLET / ORAL	AB	RLD	2003-06-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-005	BENICAR HCT	25MG;40MG	TABLET / ORAL	AB	RLD, RS	2003-06-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021532-002	BENICAR HCT	12.5MG;20MG	TABLET / ORAL	AB	RLD	2003-06-05	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N021532-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021532-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021532-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021532-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021532-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021532-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021532-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021532-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021532-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021532-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021532-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021532-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021532-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021532-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021532-005	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021532-005	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021532-005	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021532-002	AB	1	`1e350fbaab3a…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
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
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
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211
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
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3d	Product name	2	20170719
e0eeb018-194e-4b70-a57d-bac47a97b8ea	Product name	1	20160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502	Product name	2	20150320
ea069444-e874-4c28-833f-d2f52734ef4d	Product name	1	20150206
041df61b-f8b6-48a6-7b67-411e1412678b	Product name	1	20140508
0ad8bdca-888e-00da-648b-6a4de854a167	Product name	1	20140508
433a3439-b8f3-d13a-d2c8-9b221d628d60	Product name	1	20140508
59212689-39e5-a976-6d21-882d76d8079a	Product name	1	20140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212	Product name	1	20140508
78637fb0-95c8-441f-e4b4-db1274b6f956	Product name	1	20140508
df89bd47-2db4-d593-ab37-d11953fd5536	Product name	1	20140508
f151007d-265d-9fbe-857d-1d44f1cb76ba	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65597-105-30	EA - Each	65597-105	e866d406-14c1-42e3-a5ac-1c9d071abdc3	1	2012-07-24
65597-105-90	EA - Each	65597-105	676d3986-c22a-44c4-8aea-df61563773a9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
OLMESARTAN MEDOXOMIL	ACTIVE INGREDIENT	6M97XTV3HD	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
OLMESARTAN	ACTIVE MOIETY	8W1IQP3U10	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENICAR HCT (OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	10
HYDROCHLOROTHIAZIDE	ACTIVE INGREDIENT	0J48LPH2TH	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
OLMESARTAN MEDOXOMIL	ACTIVE INGREDIENT	6M97XTV3HD	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLOROTHIAZIDE	ACTIVE MOIETY	0J48LPH2TH	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
OLMESARTAN	ACTIVE MOIETY	8W1IQP3U10	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	BENICAR HCT (OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.]	1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
olmesartan medoxomil-hydrochlorothiazide	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	AvKARE	569596a2-98f0-116a-e063-6294a90a3fa1	2026-07-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532
Benicar HCT	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	Cosette Pharmaceuticals, Inc.	a90915ca-f9d3-4fff-8370-d5dc4cdfc521	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532
olmesartan medoxomil-hydrochlorothiazide	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	AvKARE	017bc6a3-5b3d-2381-e063-6394a90abece	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532
Benicar HCT	OLMESARTAN MEDOXOMIL-HYDROCHLOROTHIAZIDE	Cosette Pharmaceuticals, Inc.	881a1c32-c209-4038-9c5e-c5e46c6e0546	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021532 application number: NDA021532

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
847060	Benicar HCT 20 MG / 12.5 MG Oral Tablet	PSN	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847055	Benicar HCT 40 MG / 12.5 MG Oral Tablet	PSN	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847042	Benicar HCT 40 MG / 25 MG Oral Tablet	PSN	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403853	olmesartan medoxomil 20 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403854	olmesartan medoxomil 40 MG / hydroCHLOROthiazide 12.5 MG Oral Tablet	PSN	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403855	olmesartan medoxomil 40 MG / hydroCHLOROthiazide 25 MG Oral Tablet	PSN	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847060	hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet [Benicar HCT]	SBD	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847055	hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]	SBD	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847042	hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]	SBD	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403853	hydrochlorothiazide 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SCD	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403854	hydrochlorothiazide 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403855	hydrochlorothiazide 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SCD	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847060	Benicar HCT 20/12.5 Oral Tablet	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847055	Benicar HCT 40/12.5 Oral Tablet	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847042	Benicar HCT 40/25 Oral Tablet	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403853	HCTZ 12.5 MG / olmesartan medoxomil 20 MG Oral Tablet	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847060	HCTZ 12.5 MG / Olmesartan medoxomil 20 MG Oral Tablet [Benicar HCT]	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403854	HCTZ 12.5 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847055	HCTZ 12.5 MG / Olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
403855	HCTZ 25 MG / olmesartan medoxomil 40 MG Oral Tablet	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1
847042	HCTZ 25 MG / Olmesartan medoxomil 40 MG Oral Tablet [Benicar HCT]	SY	cd879bd1-38c0-4f72-904b-cf07f3186342	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65597-105-07	65597010507	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-105-07)	2003-07-30	0000-00-00	No	No	Current
65597-105-11	65597010511	1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-105-11)	2003-07-30	0000-00-00	No	No	Current
65597-105-30	65597010530	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-105-30)	2003-07-30	0000-00-00	No	No	Current
65597-105-90	65597010590	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-105-90)	2003-07-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Benicar HCT	Daiichi Sankyo, Inc.	2022-06-03	HUMAN PRESCRIPTION DRUG LABEL	24
Benicar Hct - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-11-30	HUMAN PRESCRIPTION DRUG LABEL	1