FDA.reportPublic FDA data

OLMESARTAN MEDOXOMIL

Product NDC
70756-809
11-digit product format
707560809
Labeler code
70756
Product ID
70756-809_45810d23-5c40-8cba-e063-6294a90a8e9c
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
OLMESARTAN MEDOXOMIL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349373, 349401, 349405

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