OLMESARTAN MEDOXOMIL

Product NDC
70756-809
11-digit product format
707560809
Labeler code
70756
Product ID
70756-809_5e7e34e7-df35-653a-e063-6394a90afa10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OLMESARTAN MEDOXOMIL
Dosage form
TABLET
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA207135
Marketing category
ANDA
Marketing start
2020-05-01
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A207135-001OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18
A207135-002OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18
A207135-003OLMESARTAN MEDOXOMILOLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207135-001AB
A207135-002AB
A207135-003AB

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18c2088c7a36db…
2026-10-15 13:18:302026-09A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18c2088c7a36db…
2026-10-15 13:18:302026-09A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18c2088c7a36db…
2026-09-14 22:38:342026-08A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-1884e616aacf4f…
2026-09-14 22:38:342026-08A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-1884e616aacf4f…
2026-09-14 22:38:342026-08A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-1884e616aacf4f…
2026-08-18 06:07:402026-07A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18caaa826d4ba7…
2026-08-18 06:07:402026-07A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18caaa826d4ba7…
2026-08-18 06:07:402026-07A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A207135-002OLMESARTAN MEDOXOMIL20MGTABLET / ORALAB2019-07-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A207135-003OLMESARTAN MEDOXOMIL40MGTABLET / ORALAB2019-07-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207135-001OLMESARTAN MEDOXOMIL5MGTABLET / ORALAB2019-07-1879d66fd596c7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A207135-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A207135-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A207135-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A207135-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A207135-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A207135-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A207135-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207135-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A207135-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207135-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207135-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207135-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207135-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207135-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207135-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207135-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207135-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207135-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207135-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207135-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207135-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207135-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207135-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207135-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207135-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207135-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207135-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207135-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207135-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207135-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207135-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207135-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207135-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207135-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207135-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207135-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207135-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207135-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A207135-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207135-001AB179d66fd596c7…

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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1

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
70756-809-30OLMESARTAN MEDOXOMIL30 in 1 BOTTLETABLET3027
70756-809-90OLMESARTAN MEDOXOMIL90 in 1 BOTTLETABLET9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-809-30EA - Each70756-809b4fc9154-fa2c-45d1-b01f-9ce60b2150a312020-07-13
70756-809-90EA - Each70756-809a3d2b58f-46f8-4f9a-b832-80733294dc7712020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-809OLMESARTAN MEDOXOMIL TABLET [LIFESTAR PHARMA LLC]26Current NDC, Legacy NDC, 2 package rows20241225_a337a621-bf57-4aa4-8224-4356fa2cdbc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNa337a621-bf57-4aa4-8224-4356fa2cdbc427
349405olmesartan medoxomil 40 MG Oral TabletPSNa337a621-bf57-4aa4-8224-4356fa2cdbc427
349373olmesartan medoxomil 5 MG Oral TabletPSNa337a621-bf57-4aa4-8224-4356fa2cdbc427
349401olmesartan medoxomil 20 MG Oral TabletSCDa337a621-bf57-4aa4-8224-4356fa2cdbc427
349405olmesartan medoxomil 40 MG Oral TabletSCDa337a621-bf57-4aa4-8224-4356fa2cdbc427
349373olmesartan medoxomil 5 MG Oral TabletSCDa337a621-bf57-4aa4-8224-4356fa2cdbc427

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-809-307075608093030 TABLET in 1 BOTTLE (70756-809-30) 30 tablet2020-05-010000-00-00NoNoCurrent
70756-809-907075608099090 TABLET in 1 BOTTLE (70756-809-90) 90 tablet2020-05-010000-00-00NoNoCurrent