OLMESARTAN MEDOXOMIL

Product NDC: 68180-724
11-digit product format: 681800724
Labeler code: 68180
Product ID: 68180-724_8dfa49ab-de71-477e-b98e-17e76eebecec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OLMESARTAN MEDOXOMIL
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Lupin Pharmaceuticals, Inc.
Application: ANDA206631
Marketing category: ANDA
Marketing start: 2017-09-01
Marketing end: 0000-00-00
Substance: OLMESARTAN MEDOXOMIL
Active strength: 5 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68180-724		D	Discontinued by firm	2026-10-12
excluded package	package	68180-724	68180-724-06	D	Discontinued by firm	2026-10-12
excluded package	package	68180-724	68180-724-09	D	Discontinued by firm	2026-10-12
excluded package	package	68180-724	68180-724-17	D	Discontinued by firm	2026-10-12

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 · 48 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	68180-724-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-724-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68180-724-09	`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	68180-724-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-724-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68180-724-09	`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	68180-724-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-724-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68180-724-09	`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	68180-724-17	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-724-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68180-724-09	`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	68180-724-17	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-724-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68180-724-09	`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	68180-724-17	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-724-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68180-724-09	`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	68180-724-17	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-724-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68180-724-09	`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	68180-724-17	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-724-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68180-724-09	`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	68180-724-17	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-724-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68180-724-09	`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	68180-724-17	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-724-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68180-724-09	`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	68180-724-17	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-724-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68180-724-09	`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	68180-724-17	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-724-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68180-724-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A206631-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27
A206631-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27
A206631-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27

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 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206631-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	2017-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206631-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	2017-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206631-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	2017-04-27	`301d65b070ca…`

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	A206631-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206631-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206631-003	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206631-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206631-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206631-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206631-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206631-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A206631-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206631-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206631-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A206631-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206631-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206631-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A206631-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206631-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206631-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A206631-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206631-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206631-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A206631-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206631-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206631-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A206631-003	AB	1	`ea99ee380514…`

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
68180-724-06	2023-10-04	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
68180-724-09	2023-10-04	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
68180-724-17	2023-10-04	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
68180-724-06	2023-01-30	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
68180-724-09	2023-01-30	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
68180-724-17	2023-01-30	These highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68180-724-06	EA - Each	68180-724	841ea1fe-9c8b-4a0b-abc0-e9207683e54d	1	2017-09-11

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
68180-724-06	68180072406	30 TABLET, FILM COATED in 1 BOTTLE (68180-724-06)	2017-09-01	0000-00-00	No	No	Current
68180-724-09	68180072409	90 TABLET, FILM COATED in 1 BOTTLE (68180-724-09)	2017-09-01	0000-00-00	No	No	Current
68180-724-17	68180072417	300 TABLET, FILM COATED in 1 BOTTLE (68180-724-17)	2017-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
OLMESARTAN MEDOXOMIL	Lupin Pharmaceuticals, Inc. \| LUPIN LIMITED	2020-12-24	HUMAN PRESCRIPTION DRUG LABEL	8