Olmesartan Medoxomil

Product NDC: 68462-437
11-digit product format: 684620437
Labeler code: 68462
Product ID: 68462-437_3d590efe-ccb3-4ca3-b49e-9547dd674eae
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Glenmark Pharmaceuticals Inc., USA
Application: ANDA203281
Marketing category: ANDA
Marketing start: 2017-05-25
Substance: OLMESARTAN MEDOXOMIL
Active strength: 20 mg/1
Pharmacologic classes: Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: 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	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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Olmesartan Medoxomil
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6M97XTV3HD	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349373	Internal RxNorm lookup
349401	Internal RxNorm lookup
349405	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8e0adf3d-7569-4909-bab1-5fed9578ad77	Available on FDA.report

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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68462-437-10	Olmesartan Medoxomil	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	8
68462-437-11	Olmesartan Medoxomil	10 in 1 CARTON	TABLET, FILM COATED	10	8
68462-437-11	Olmesartan Medoxomil	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	8
68462-437-30	Olmesartan Medoxomil	30 in 1 BOTTLE	TABLET, FILM COATED	30	8
68462-437-90	Olmesartan Medoxomil	90 in 1 BOTTLE	TABLET, FILM COATED	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68462-437-30	EA - Each	68462-437	afc46235-dd11-4c04-895d-23086df371a3	1	2017-06-15
68462-437-90	EA - Each	68462-437	aa992def-b414-4db8-9613-200dd619ccc2	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68462-437	OLMESARTAN MEDOXOMIL TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]	7	Current NDC, Legacy NDC, 5 package rows	20230113_8e0adf3d-7569-4909-bab1-5fed9578ad77.zip

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 ndc (product): 68462-437

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
349401	olmesartan medoxomil 20 MG Oral Tablet	PSN	8e0adf3d-7569-4909-bab1-5fed9578ad77	8
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	8e0adf3d-7569-4909-bab1-5fed9578ad77	8
349373	olmesartan medoxomil 5 MG Oral Tablet	PSN	8e0adf3d-7569-4909-bab1-5fed9578ad77	8
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	8e0adf3d-7569-4909-bab1-5fed9578ad77	8
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	8e0adf3d-7569-4909-bab1-5fed9578ad77	8
349373	olmesartan medoxomil 5 MG Oral Tablet	SCD	8e0adf3d-7569-4909-bab1-5fed9578ad77	8
349401	olmesartan medoxomil 20 MG Oral Tablet	PSN	5972c6fd-08e3-4189-a894-1ba220b57e80	3
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	5972c6fd-08e3-4189-a894-1ba220b57e80	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68462-437-10	68462043710	1000 TABLET, FILM COATED in 1 BOTTLE (68462-437-10)		2017-05-25	0000-00-00	No	No	Current
68462-437-11	68462043711	10 BLISTER PACK in 1 CARTON (68462-437-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK	10 blister pack	2017-05-25	0000-00-00	No	No	Current
68462-437-30	68462043730	30 TABLET, FILM COATED in 1 BOTTLE (68462-437-30)		2017-05-25	0000-00-00	No	No	Current
68462-437-90	68462043790	90 TABLET, FILM COATED in 1 BOTTLE (68462-437-90)		2017-05-25	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Olmesartan Medoxomil	A-S Medication Solutions	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	3
Olmesartan Medoxomil	Glenmark Pharmaceuticals Inc., USA \| Glenmark Pharmaceuticals Limited	2026-01-30	HUMAN PRESCRIPTION DRUG LABEL	8