FDA.reportPublic FDA data

Benicar

Product NDC
0713-0860
11-digit product format
007130860
Labeler code
0713
Product ID
0713-0860_00494313-514a-b3b5-e063-6294a90a5ad5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
olmesartan medoxomil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
NDA021286
Marketing category
NDA
Marketing start
2022-09-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OLMESARTAN MEDOXOMIL5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii6M97XTV3HD
Rxcui349373, 349401, 349405, 352199, 352200, 352201

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
0713-0860-302024-01-30C16284748780-11030e365-567a-111a-e063-dadaa90a10e2These 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
0713-0860-30Benicar30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0860-30EA - Each0713-0860d46684a4-f015-4447-9f6a-e7f16df1fb9e12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0860BENICAR (OLMESARTAN MEDOXOMIL) TABLET, FILM COATED [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 1 package rows20230713_5b6f8a18-8f8a-4521-81c3-3a39c73c6646.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
352200Benicar 20 MG Oral TabletPSN5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352201Benicar 40 MG Oral TabletPSN5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352199Benicar 5 MG Oral TabletPSN5b6f8a18-8f8a-4521-81c3-3a39c73c66463
349401olmesartan medoxomil 20 MG Oral TabletPSN5b6f8a18-8f8a-4521-81c3-3a39c73c66463
349405olmesartan medoxomil 40 MG Oral TabletPSN5b6f8a18-8f8a-4521-81c3-3a39c73c66463
349373olmesartan medoxomil 5 MG Oral TabletPSN5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352200olmesartan medoxomil 20 MG Oral Tablet [Benicar]SBD5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352201olmesartan medoxomil 40 MG Oral Tablet [Benicar]SBD5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352199olmesartan medoxomil 5 MG Oral Tablet [Benicar]SBD5b6f8a18-8f8a-4521-81c3-3a39c73c66463
349401olmesartan medoxomil 20 MG Oral TabletSCD5b6f8a18-8f8a-4521-81c3-3a39c73c66463
349405olmesartan medoxomil 40 MG Oral TabletSCD5b6f8a18-8f8a-4521-81c3-3a39c73c66463
349373olmesartan medoxomil 5 MG Oral TabletSCD5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352200Benicar 20 MG Oral TabletSY5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352201Benicar 40 MG Oral TabletSY5b6f8a18-8f8a-4521-81c3-3a39c73c66463
352199Benicar 5 MG Oral TabletSY5b6f8a18-8f8a-4521-81c3-3a39c73c66463

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0713-0860-300071308603030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0713-0860-30) 2022-09-010000-00-00NoNoCurrent