FDA.reportPublic FDA data

Benicar

Product NDC
65597-101
11-digit product format
655970101
Labeler code
65597
Product ID
65597-101_9a1acd82-0655-4e72-9177-12ddf31c4b1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Daiichi Sankyo, Inc.
Application
NDA021286
Marketing category
NDA
Marketing start
2002-04-25
Marketing end
2024-01-31
Substance
OLMESARTAN MEDOXOMIL
Active strength
5 mg/1
Pharmacologic classes
Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65597-101-30EA - Each65597-101553b9211-bf9c-411c-b78b-cfb72a1ab9ef12012-07-24

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
OLMESARTAN MEDOXOMILACTIVE INGREDIENT6M97XTV3HDBENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
OLMESARTANACTIVE MOIETY8W1IQP3U10BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2

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
352199Benicar 5 MG Oral TabletPSNb2d10788-e0e4-4ee8-8c47-d7f7ed44e3d93
349373olmesartan medoxomil 5 MG Oral TabletPSNb2d10788-e0e4-4ee8-8c47-d7f7ed44e3d93
352199olmesartan medoxomil 5 MG Oral Tablet [Benicar]SBDb2d10788-e0e4-4ee8-8c47-d7f7ed44e3d93
349373olmesartan medoxomil 5 MG Oral TabletSCDb2d10788-e0e4-4ee8-8c47-d7f7ed44e3d93
352199Benicar 5 MG Oral TabletSYb2d10788-e0e4-4ee8-8c47-d7f7ed44e3d93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65597-101-306559701013030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (65597-101-30) 2002-04-250000-00-00NoNoCurrent