Olmesartan Medoxomil

Product NDC: 60505-4652
Requested package NDC: 60505-4652-3
11-digit product format: 605054652
Labeler code: 60505
Product ID: 60505-4652_ddf48401-f0f4-87ac-f6c6-da7d9d555a29
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Apotex Corp.
Application: ANDA203281
Marketing category: ANDA
Marketing start: 2018-08-23
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	60505-4652	60505-4652-3	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 · 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 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	Approval date
A203281-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25
A203281-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25
A203281-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203281-001	AB
A203281-002	AB
A203281-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2017-05-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203281-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2017-05-25	`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	A203281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203281-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203281-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203281-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203281-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203281-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203281-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203281-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203281-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203281-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203281-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203281-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203281-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203281-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203281-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
60505-4652-3	EA - Each	60505-4652	b1d6ae33-53fe-437f-a0d7-bd1f2d014c53	1	2018-08-13

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	5972c6fd-08e3-4189-a894-1ba220b57e80	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	57dc737b-01e2-4b22-991f-d4710950dcf3	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	67aa498d-edf6-45b8-a3fd-019c3fb76960	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	8acdc142-aa38-4fcb-bd15-fbba9635a4c6	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Glenmark Pharmaceuticals Inc., USA	8e0adf3d-7569-4909-bab1-5fed9578ad77	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203281 application number: ANDA203281

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
60505-4652-3	60505465203	30 TABLET, FILM COATED in 1 BOTTLE (60505-4652-3)	2018-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil	Apotex Corp. \| Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Ltd.	2019-11-20	HUMAN PRESCRIPTION DRUG LABEL	3