Application 021286

Type: NDA
Sponsor: DAIICHI SANKYO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BENICAR	OLMESARTAN MEDOXOMIL	TABLET;ORAL	5MG	Yes	No
003	BENICAR	OLMESARTAN MEDOXOMIL	TABLET;ORAL	20MG	Yes	No
004	BENICAR	OLMESARTAN MEDOXOMIL	TABLET;ORAL	40MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021286-001	BENICAR	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	RLD	2002-04-25
N021286-003	BENICAR	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	RLD	2002-04-25
N021286-004	BENICAR	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021286-001	AB
N021286-003	AB
N021286-004	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 · 123 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
2026-02-19 14:30 UTC	2026-02	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-003	BENICAR	20MG	TABLET / ORAL	AB	RLD	2002-04-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-004	BENICAR	40MG	TABLET / ORAL	AB	RLD, RS	2002-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021286-001	BENICAR	5MG	TABLET / ORAL	AB	RLD	2002-04-25	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021286-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021286-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021286-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021286-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021286-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021286-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021286-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021286-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021286-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021286-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021286-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021286-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021286-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021286-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021286-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021286-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021286-001	AB	1	`8072bd15b7f6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Benicar	OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	dc3f1fd4-5578-4c5d-be7b-12e3f8f3e7df	2025-09-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021286 application number: NDA021286
Benicar	OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	5b6f8a18-8f8a-4521-81c3-3a39c73c6646	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021286 application number: NDA021286 ndc (product): 0713-0860 ndc (product): 0713-0862 ndc (product): 0713-0861

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0713-0860	Benicar	olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0860	Benicar	olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0861	Benicar	olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0861	Benicar	olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0862	Benicar	olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
0713-0862	Benicar	olmesartan medoxomil	Cosette Pharmaceuticals, Inc.	NDA	Current
50090-0877	Benicar	olmesartan medoxomil	A-S Medication Solutions	NDA	Current
50090-0877	Benicar	olmesartan medoxomil	A-S Medication Solutions	NDA	Current
51138-211	Benicar	olmesartan medoxomil	Med-Health Pharma, LLC	NDA	Current
51138-212	Benicar	olmesartan medoxomil	Med-Health Pharma, LLC	NDA	Current
51138-213	Benicar	olmesartan medoxomil	Med-Health Pharma, LLC	NDA	Current
55154-6130	Benicar	olmesartan medoxomil	Cardinal Health	NDA	Current
55289-436	Benicar	olmesartan medoxomil	PD-Rx Pharmaceuticals, Inc.	NDA	Current
57664-755	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-755	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-755	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-755	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-756	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-756	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-756	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-756	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-757	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
57664-757	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-757	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA AUTHORIZED GENERIC	Current
57664-757	Olmesartan Medoxomil	olmesartan medoxomil	Sun Pharmaceutical Industries, Inc.	NDA	Current
63629-3390	Benicar	olmesartan medoxomil	Bryant Ranch Prepack	NDA	Current
65597-101	Benicar	olmesartan medoxomil	Daiichi Sankyo, Inc.	NDA	Current
65597-101	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-101	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-101	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-101	Benicar	olmesartan medoxomil	Daiichi Sankyo, Inc.	NDA	Current
65597-103	Benicar	olmesartan medoxomil	Daiichi Sankyo, Inc.	NDA	Current
65597-103	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-103	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-103	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-103	Benicar	olmesartan medoxomil	Daiichi Sankyo, Inc.	NDA	Current
65597-104	Benicar	olmesartan medoxomil	Daiichi Sankyo, Inc.	NDA	Current
65597-104	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-104	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-104	Benicar	olmesartan medoxomil	Daiichi Sankyo Inc.	NDA	Current
65597-104	Benicar	olmesartan medoxomil	Daiichi Sankyo, Inc.	NDA	Current
68151-4633	Benicar	olmesartan medoxomil	Carilion Materials Management	NDA	Current
71335-0197	Olmesartan Medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	NDA	Current
71335-0197	Olmesartan Medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	NDA	Current
71335-0197	Olmesartan Medoxomil	olmesartan medoxomil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60587	SUPPL	2019-10-18
60584	SUPPL	2019-10-18
45778	SUPPL	2016-11-02
45773	SUPPL	2016-11-01
21576	SUPPL	2015-07-21
36590	SUPPL	2014-09-26
4926	SUPPL	2014-09-24
36589	SUPPL	2014-06-30
27384	SUPPL	2014-06-30
14890	SUPPL	2014-06-17
4925	SUPPL	2014-06-17
27383	SUPPL	2013-07-05
14889	SUPPL	2013-07-05
36588	SUPPL	2012-12-13
27382	SUPPL	2012-12-11
27381	SUPPL	2012-10-03
36587	SUPPL	2012-10-02
4924	SUPPL	2012-04-02
36586	SUPPL	2012-03-30
36585	SUPPL	2012-02-17
27380	SUPPL	2012-02-17
4923	SUPPL	2011-06-07
36584	SUPPL	2011-06-06
4922	SUPPL	2011-05-24
36583	SUPPL	2011-05-23
27379	SUPPL	2010-02-17
14888	SUPPL	2010-02-16
4921	SUPPL	2007-10-04
14887	SUPPL	2005-07-15
4920	SUPPL	2005-07-15
27378	SUPPL	2004-11-16
4919	SUPPL	2003-02-12
27377	SUPPL	2002-10-25
21575	ORIG	2002-07-05
14886	ORIG	2002-04-25
4918	ORIG	2002-04-25
64056	ORIG	1900-01-01
64055	ORIG	1900-01-01
58109	ORIG	1900-01-01
53355	ORIG	1900-01-01
53354	ORIG	1900-01-01
53353	ORIG	1900-01-01