FDA.reportPublic FDA data

Olmesartan Medoxomil

Product NDC
50090-4451
11-digit product format
500904451
Labeler code
50090
Product ID
50090-4451_65f41aa8-81da-4c9d-a51d-56f811bd91a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Olmesartan Medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203281
Marketing category
ANDA
Marketing start
2017-05-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Olmesartan Medoxomil
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349405

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4451-02023-01-30C16284748780-1f386c64a-17f8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002
50090-4451-12023-01-30C16284748780-1f386c64a-17f8-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OLMESARTAN MEDOXOMIL TABLETS safely and effectively. See full prescribing information for OLMESARTAN MEDOXOMIL TABLETS. OLMESARTAN MEDOXOMIL tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4451-0Olmesartan Medoxomil30 in 1 BOTTLETABLET, FILM COATED307
50090-4451-1Olmesartan Medoxomil90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4451OLMESARTAN MEDOXOMIL TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20210417_67aa498d-edf6-45b8-a3fd-019c3fb76960.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349405olmesartan medoxomil 40 MG Oral TabletPSN67aa498d-edf6-45b8-a3fd-019c3fb769607
349405olmesartan medoxomil 40 MG Oral TabletSCD67aa498d-edf6-45b8-a3fd-019c3fb769607

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4451-05009044510030 TABLET, FILM COATED in 1 BOTTLE (50090-4451-0) 2019-08-050000-00-00NoNoCurrent
50090-4451-15009044510190 TABLET, FILM COATED in 1 BOTTLE (50090-4451-1) 2019-08-050000-00-00NoNoCurrent