Olmesartan Medoxomil

Product NDC: 62135-881
11-digit product format: 621350881
Labeler code: 62135
Product ID: 62135-881_46879df5-2a7d-8b49-e063-6294a90ad4b7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Olmesartan Medoxomil
Dosage form: TABLET
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA211049
Marketing category: ANDA
Marketing start: 2019-03-05
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: 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
A211049-001	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22
A211049-002	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22
A211049-003	OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211049-001	AB
A211049-002	AB
A211049-003	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	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-002	OLMESARTAN MEDOXOMIL	20MG	TABLET / ORAL	AB	2019-02-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-003	OLMESARTAN MEDOXOMIL	40MG	TABLET / ORAL	AB	2019-02-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211049-001	OLMESARTAN MEDOXOMIL	5MG	TABLET / ORAL	AB	2019-02-22	`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	A211049-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211049-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211049-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211049-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211049-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211049-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211049-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211049-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211049-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211049-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211049-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211049-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211049-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211049-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211049-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211049-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211049-001	AB	1	`8072bd15b7f6…`

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	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
7835d2b0-8e5d-4d3f-a95f-9252fb65025b	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	Strength	SPL version
62135-881-30	Olmesartan Medoxomil	30 in 1 BOTTLE	TABLET	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-881-30	EA - Each	62135-881	43d39a07-2200-4b78-ab91-488f733a7a30	1	2024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-881	OLMESARTAN MEDOXOMIL TABLET [CHARTWELL RX, LLC]	1	Current NDC, 1 package rows	20240424_7835d2b0-8e5d-4d3f-a95f-9252fb65025b.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	HEC Pharm USA Inc.	4f4d89ab-58c8-27ea-e063-6394a90a8723	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
Olmesartan Medoxomil	OLMESARTAN MEDOXOMIL	Chartwell RX, LLC	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049 ndc (product): 62135-881
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	3c001b8d-f6c1-4316-b8c0-590b2fa7f2e5	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	A-S Medication Solutions	38f7f201-3a3a-4922-bde7-d34187b4c81d	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049
OLMESARTAN MEDOXOMIL	OLMESARTAN MEDOXOMIL	Lannett Company, Inc.	c620361a-dc2d-28a1-e053-2995a90abd14	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211049 application number: ANDA211049

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	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2
349405	olmesartan medoxomil 40 MG Oral Tablet	PSN	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2
349373	olmesartan medoxomil 5 MG Oral Tablet	PSN	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2
349401	olmesartan medoxomil 20 MG Oral Tablet	SCD	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2
349405	olmesartan medoxomil 40 MG Oral Tablet	SCD	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2
349373	olmesartan medoxomil 5 MG Oral Tablet	SCD	7835d2b0-8e5d-4d3f-a95f-9252fb65025b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-881-30	62135088130	30 TABLET in 1 BOTTLE (62135-881-30)	30 tablet	2024-04-05	No	No	Current