Azor

Product NDC: 65597-112
Requested package NDC: 65597-112-07
11-digit product format: 655970112
Labeler code: 65597
Product ID: 65597-112_d5485e0f-7c18-4073-91f6-0890243d9bd6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: amlodipine besylate and olmesartan medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Daiichi Sankyo Inc.
Application: NDA022100
Marketing category: NDA
Marketing start: 2007-09-26
Marketing end: 2023-10-31
Substance: AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
Active strength: 5 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]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	65597-112	65597-112-07	D	Discontinued by firm		2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022100-001	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26
N022100-002	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26
N022100-003	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26
N022100-004	AZOR	AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022100-001	AB
N022100-002	AB
N022100-003	AB
N022100-004	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 5 · 172 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	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-001	AZOR	EQ 5MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-002	AZOR	EQ 5MG BASE;40MG	TABLET / ORAL	AB	RLD	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-003	AZOR	EQ 10MG BASE;20MG	TABLET / ORAL	AB	RLD	2007-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-004	AZOR	EQ 10MG BASE;40MG	TABLET / ORAL	AB	RLD, RS	2007-09-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	N022100-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022100-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022100-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022100-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022100-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022100-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022100-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022100-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022100-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022100-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022100-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022100-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022100-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022100-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
65597-112-07	2020-08-14	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-10	2020-08-14	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-11	2020-08-14	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-30	2020-08-14	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-90	2020-08-14	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-07	2020-07-22	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-10	2020-07-22	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-11	2020-07-22	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-30	2020-07-22	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7
65597-112-90	2020-07-22	These highlights do not include all the information needed to use AZOR safely and effectively. See full prescribing information for AZOR . AZOR (amlodipine and olmesartan medoxomil) tablets , for oral use Initial U.S. Approval: 200 7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65597-112-10	EA - Each	65597-112	07377290-ad67-4371-a93f-06b9b2d3e5b1	1	2015-10-02
65597-112-30	EA - Each	65597-112	8008207a-1c8a-4cb6-8e39-469af97c3bb5	1	2012-07-24
65597-112-90	EA - Each	65597-112	300d72f9-e542-4354-9dcb-63c92db031db	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AMLODIPINE BESYLATE	ACTIVE INGREDIENT	864V2Q084H	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
OLMESARTAN MEDOXOMIL	ACTIVE INGREDIENT	6M97XTV3HD	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
AMLODIPINE	ACTIVE MOIETY	1J444QC288	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
OLMESARTAN	ACTIVE MOIETY	8W1IQP3U10	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	AZOR (AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [DAIICHI SANKYO, INC.]	15

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
amlodipine besylate and olmesartan medoxomil	AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL	Golden State Medical Supply, Inc.	132cca8f-48a2-2516-e063-6394a90a5f32	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022100 application number: NDA022100
Azor	AMLODIPINE BESYLATE AND OLMESARTAN MEDOXOMIL	Cosette Pharmaceuticals, Inc.	c5535406-b63b-49aa-88b9-169aaf0ed08e	2023-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022100 application number: NDA022100

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
864V2Q084H	AMLODIPINE BESYLATE	111470-99-6	AMLODIPINE BESYLATE
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
65597-112-07	65597011207	7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-112-07)	2007-09-26	2023-10-31	No	No	Current