olmesartan medoxomil

Product NDC: 70518-4053
Requested package NDC: 70518-4053-1
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#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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): 70518-4053-1 ndc (product): 70518-4053 ndc11 (package): 70518405301
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
70518-4053-1	70518405301	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4053-1)	2025-03-20	No	No	Current