FDA.reportPublic FDA data

Benicar

Product NDC
51138-213
11-digit product format
511380213
Labeler code
51138
Product ID
51138-213_44f7fd62-0be0-4a87-a89e-036a0445016c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Med-Health Pharma, LLC
Application
NDA021286
Marketing category
NDA
Marketing start
2012-02-02
Marketing end
0000-00-00
Substance
OLMESARTAN MEDOXOMIL
Active strength
40 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA],Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
51138-213-302019-11-27C16284748780-19855d018-d4ae-cd31-e053-dbdaa90ab51aThese highlights do not include all the information needed to use BENICAR safely and effectively. See full prescribing information for BENICAR. BENICAR (olmesartan medoxomil) tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51138-213-30Benicar30 in 1 BOTTLE, PLASTICTABLET, FILM COATED307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-213-30EA - Each51138-213f2b08102-c3d2-4184-8888-8e54c8b3700512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OLMESARTAN MEDOXOMILACTIVE INGREDIENT6M97XTV3HDBENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]7
OLMESARTANACTIVE MOIETY8W1IQP3U10BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-213BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [MED-HEALTH PHARMA, LLC]7Legacy NDC, 1 package rows20130208_18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352200Benicar 20 MG Oral TabletPSN18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352201Benicar 40 MG Oral TabletPSN18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352199Benicar 5 MG Oral TabletPSN18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
349401olmesartan medoxomil 20 MG Oral TabletPSN18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
349405olmesartan medoxomil 40 MG Oral TabletPSN18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
349373olmesartan medoxomil 5 MG Oral TabletPSN18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352200olmesartan medoxomil 20 MG Oral Tablet [Benicar]SBD18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352201olmesartan medoxomil 40 MG Oral Tablet [Benicar]SBD18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352199olmesartan medoxomil 5 MG Oral Tablet [Benicar]SBD18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
349401olmesartan medoxomil 20 MG Oral TabletSCD18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
349405olmesartan medoxomil 40 MG Oral TabletSCD18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
349373olmesartan medoxomil 5 MG Oral TabletSCD18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352200Benicar 20 MG Oral TabletSY18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352201Benicar 40 MG Oral TabletSY18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7
352199Benicar 5 MG Oral TabletSY18f1a4fc-dfca-4dde-8a11-f7e6d9e5656d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-213-305113802133030 in 1 BOTTLE, PLASTICHistorical