OLMESARTAN MEDOXOMIL

Product NDC
64980-601
11-digit product format
649800601
Labeler code
64980
Product ID
64980-601_4e8b4338-7c4c-4af4-8658-660111a8b966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA208659
Marketing category
ANDA
Marketing start
2024-03-30
Marketing end
2026-06-30
Substance
OLMESARTAN MEDOXOMIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct64980-601DDiscontinued by firm2026-08-17
excluded packagepackage64980-60164980-601-03DDiscontinued by firm2026-08-17
excluded packagepackage64980-60164980-601-09DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208659-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18
A208659-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18
A208659-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A208659-001AB
A208659-002AB
A208659-003AB

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 3 · 114 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18caaa826d4ba7…
2026-08-18 06:07:402026-07A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208659-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2020-05-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208659-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2020-05-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208659-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2020-05-181e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A208659-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208659-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A208659-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208659-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208659-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A208659-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208659-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208659-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208659-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208659-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208659-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A208659-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208659-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208659-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208659-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208659-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208659-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208659-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208659-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208659-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208659-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208659-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208659-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208659-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208659-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208659-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208659-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208659-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208659-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208659-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208659-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208659-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A208659-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208659-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208659-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208659-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208659-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208659-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208659-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208659-001AB11e350fbaab3a…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
caadbc51-b731-1a7b-b91a-f7bb4a62554eProduct name920240306
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-601-03OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET, COATED303
64980-601-09OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET, COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-601-03EA - Each64980-601a39b42a7-cbfb-4af2-9fb2-e7a8a8264e1d12024-06-10
64980-601-09EA - Each64980-60183635e8a-c6b3-4579-a2b5-ffa13089957a12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-601OLMESARTAN MEDOXOMIL TABLET, COATED [RISING PHARMA HOLDINGS, INC.]3Current NDC, 2 package rows20241019_b02ff20e-3f0e-43f4-a7b5-6ce56295d023.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILBryant Ranch Prepack1df1ff60-6be5-4018-a28c-0d23e5867eba2026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208659
application number: ANDA208659
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILRising Pharma Holdings, Inc.b02ff20e-3f0e-43f4-a7b5-6ce56295d0232024-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208659
application number: ANDA208659
ndc (product): 64980-601
OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMILInventia Healthcare Limited05a807bf-5175-43a2-a676-215bba2645a82023-09-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 208659
application number: ANDA208659

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349405olmesartan medoxomil 40 MG Oral TabletPSNb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349373olmesartan medoxomil 5 MG Oral TabletPSNb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349401olmesartan medoxomil 20 MG Oral TabletSCDb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349405olmesartan medoxomil 40 MG Oral TabletSCDb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349373olmesartan medoxomil 5 MG Oral TabletSCDb02ff20e-3f0e-43f4-a7b5-6ce56295d0233
349373olmesartan medoxomil 5 MG Oral TabletPSNecbb9e05-d590-423f-b530-141f617d5a931
349373olmesartan medoxomil 5 MG Oral TabletSCDecbb9e05-d590-423f-b530-141f617d5a931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
64980-601-036498006010330 in 1 BOTTLEHistorical
64980-601-096498006010990 TABLET, COATED in 1 BOTTLE (64980-601-09) 2024-03-302026-06-30NoNoHistorical