olmesartan medoxomil

Product NDC: 70518-4053
Requested package NDC: 70518-4053-2
11-digit product format: 705184053
Labeler code: 70518
Product ID: 70518-4053_3fa20044-d4cd-ebda-e063-6294a90af1a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: olmesartan medoxomil
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA208130
Marketing category: ANDA
Marketing start: 2024-04-16
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: 2026-12-31
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
A208130-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29
A208130-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29
A208130-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208130-001	AB
A208130-002	AB
A208130-003	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	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2018-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208130-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2018-06-29	`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	A208130-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208130-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208130-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208130-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208130-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208130-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208130-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208130-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208130-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208130-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208130-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208130-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208130-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208130-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208130-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208130-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208130-001	AB	1	`8072bd15b7f6…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Direct_Rx	4a2aad53-fcba-2a61-e063-6394a90a6016	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	fe6e39da-fb6e-46da-9c03-c765020a7c87	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Golden State Medical Supply, Inc.	865c2765-5072-d029-e053-2a91aa0a098e	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	8466711a-3a02-4675-96db-c7cffdb89778	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	640936ee-55a6-47ae-a1ad-cffae316b925	2025-10-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	REMEDYREPACK INC.	1be698df-30a0-4117-8c24-7253af94c8ad	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130 ndc (package): 70518-4053-2 ndc (product): 70518-4053 ndc11 (package): 70518405302
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	25431c8c-9f6e-42e7-ab84-4b062755bfe3	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	fe80fd21-fa8d-474e-ac0a-23f0e1eb7f3b	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	c35408d2-a4b5-43de-8dab-f74a60fa9853	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	Bryant Ranch Prepack	409e06ad-2ea9-4b47-829e-57139e22eac9	2023-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130
olmesartan medoxomil	OLMESARTAN MEDOXOMIL	ScieGen Pharmaceuticals, Inc.	f15664a4-6b5f-4e88-ad56-c827ed90a40c	2021-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208130 application number: ANDA208130

Additional Listing Data#

Finished product: Yes
Brand name base: olmesartan medoxomil
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OLMESARTAN MEDOXOMIL	40 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
1be698df-30a0-4117-8c24-7253af94c8ad	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
70518-4053-0	olmesartan medoxomil	90 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	90	4
70518-4053-1	olmesartan medoxomil	100 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	100	4
70518-4053-2	olmesartan medoxomil	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4053	OLMESARTAN MEDOXOMIL TABLET, FILM COATED [REMEDYREPACK INC.]	3	Current NDC, 3 package rows	20250508_1be698df-30a0-4117-8c24-7253af94c8ad.zip

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	1be698df-30a0-4117-8c24-7253af94c8ad	4
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	1be698df-30a0-4117-8c24-7253af94c8ad	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
70518-4053-2	70518405302	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4053-2)	2025-05-06	No	No	Current