Olmesartan Medoxomil

Product NDC: 0093-7612
11-digit product format: 000937612
Labeler code: 0093
Product ID: 0093-7612_387f9f5f-a7d0-46d6-803e-7682600df334
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA091079
Marketing category: ANDA
Marketing start: 2017-04-24
Marketing end: 2019-11-30
Substance: OLMESARTAN MEDOXOMIL
Active strength: 40 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
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	0093-7612		D	Discontinued by firm	2026-08-03
excluded package	package	0093-7612	0093-7612-56	D	Discontinued by firm	2026-08-03
excluded package	package	0093-7612	0093-7612-98	D	Discontinued by firm	2026-08-03

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 · 36 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	0093-7612-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0093-7612-98	`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	0093-7612-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0093-7612-98	`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	0093-7612-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0093-7612-98	`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	0093-7612-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0093-7612-98	`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	0093-7612-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0093-7612-98	`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	0093-7612-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0093-7612-98	`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	0093-7612-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0093-7612-98	`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	0093-7612-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0093-7612-98	`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	0093-7612-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0093-7612-98	`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	0093-7612-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0093-7612-98	`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	0093-7612-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0093-7612-98	`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	0093-7612-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0093-7612-98	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A091079-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24
A091079-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24
A091079-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091079-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091079-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091079-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-24	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091079-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091079-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091079-003	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A091079-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091079-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091079-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091079-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091079-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091079-003	AB	1	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1	Product name	3	20260303
96816964-c075-ffa7-b7b8-d8570411a3b9	Product name	7	20250305
caadbc51-b731-1a7b-b91a-f7bb4a62554e	Product name	9	20240306
4a27501f-a987-48a5-99b4-e983d4744d76	Product name	7	20181211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7612-56	EA - Each	0093-7612	0496225a-1075-44df-b58f-fc69d8b2fb93	1	2017-05-03
0093-7612-98	EA - Each	0093-7612	5e1e6752-a996-42e7-b561-3e4b47cef4dc	1	2017-05-03

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6M97XTV3HD	OLMESARTAN MEDOXOMIL	144689-63-4	OLMESARTAN MEDOXOMIL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	db1967f5-89d9-4291-98f1-0520d6917ecf	1
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	db1967f5-89d9-4291-98f1-0520d6917ecf	1

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil	A-S Medication Solutions	2018-05-09	HUMAN PRESCRIPTION DRUG LABEL	1
Olmesartan Medoxomil	Bryant Ranch Prepack	2017-05-19	HUMAN PRESCRIPTION DRUG LABEL	1
Olmesartan Medoxomil	Teva Pharmaceuticals USA, Inc.	2017-05-01	HUMAN PRESCRIPTION DRUG LABEL	3