FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
71205-459
11-digit product format
712050459
Labeler code
71205
Product ID
71205-459_596ef2af-5b28-47f5-a9ef-48b2ece886c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA206763
Marketing category
ANDA
Marketing start
2017-04-24
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

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 Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349401, 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
71205-459-30Olmesartan Medoxomil30 in 1 BOTTLETABLET, COATED302
71205-459-90Olmesartan Medoxomil90 in 1 BOTTLETABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-459OLMESARTAN MEDOXOMIL TABLET, COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 2 package rows20241129_eff8b514-bb7f-427e-a267-7dee25fff611.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349401olmesartan medoxomil 20 MG Oral TabletPSNeff8b514-bb7f-427e-a267-7dee25fff6112
349405olmesartan medoxomil 40 MG Oral TabletPSNeff8b514-bb7f-427e-a267-7dee25fff6112
349401olmesartan medoxomil 20 MG Oral TabletSCDeff8b514-bb7f-427e-a267-7dee25fff6112
349405olmesartan medoxomil 40 MG Oral TabletSCDeff8b514-bb7f-427e-a267-7dee25fff6112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-459-307120504593030 TABLET, COATED in 1 BOTTLE (71205-459-30) 2020-06-240000-00-00NoNoCurrent
71205-459-907120504599090 TABLET, COATED in 1 BOTTLE (71205-459-90) 2024-11-22NoNoCurrent