Olmesartan Medoxomil

Product NDC
72241-080
Requested package NDC
72241-080-22
11-digit product format
722410080
Labeler code
72241
Product ID
72241-080_1f430fc9-bd4c-4328-a4a2-501ec991029b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA210682
Marketing category
ANDA
Marketing start
2025-07-01
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 43.

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
A210682-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-08
A210682-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-08
A210682-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210682-001AB
A210682-002AB
A210682-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-0884e616aacf4f…
2026-09-14 22:38:342026-08A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-0884e616aacf4f…
2026-08-18 06:07:402026-07A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-08caaa826d4ba7…
2026-08-18 06:07:402026-07A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-082680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210682-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2024-11-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210682-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2024-11-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210682-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2024-11-08a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A210682-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A210682-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A210682-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A210682-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210682-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210682-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210682-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210682-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210682-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210682-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210682-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210682-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210682-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210682-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210682-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210682-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210682-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210682-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210682-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210682-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210682-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210682-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210682-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210682-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210682-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210682-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210682-003AB12680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210682-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210682-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A210682-003AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6M97XTV3HDInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1f430fc9-bd4c-4328-a4a2-501ec991029bAvailable on FDA.report

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
72241-080-04Olmesartan Medoxomil90 in 1 BOTTLETABLET, COATED901
72241-080-10Olmesartan Medoxomil500 in 1 BOTTLETABLET, COATED5001
72241-080-22Olmesartan Medoxomil30 in 1 BOTTLETABLET, COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-080-04EA - Each72241-080cd81633e-8973-4aa4-b98c-88481298d5a612026-05-22

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Olmesartan MedoxomilOLMESARTAN MEDOXOMILModavar Pharmaceuticals LLC1f430fc9-bd4c-4328-a4a2-501ec991029b2025-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210682
application number: ANDA210682
ndc (package): 72241-080-22
ndc (product): 72241-080
ndc11 (package): 72241008022
Olmesartan MedoxomilOLMESARTAN MEDOXOMILCadila Pharmaceuticals Limitedc5416a9f-1dcc-4851-bbc0-6664d22fc8fa2024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 210682
application number: ANDA210682

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSN1f430fc9-bd4c-4328-a4a2-501ec991029b1
349405olmesartan medoxomil 40 MG Oral TabletPSN1f430fc9-bd4c-4328-a4a2-501ec991029b1
349373olmesartan medoxomil 5 MG Oral TabletPSN1f430fc9-bd4c-4328-a4a2-501ec991029b1
349401olmesartan medoxomil 20 MG Oral TabletSCD1f430fc9-bd4c-4328-a4a2-501ec991029b1
349405olmesartan medoxomil 40 MG Oral TabletSCD1f430fc9-bd4c-4328-a4a2-501ec991029b1
349373olmesartan medoxomil 5 MG Oral TabletSCD1f430fc9-bd4c-4328-a4a2-501ec991029b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72241-080-227224100802230 TABLET, COATED in 1 BOTTLE (72241-080-22) 2025-07-01NoNoCurrent