FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
54458-863
11-digit product format
544580863
Labeler code
54458
Product ID
54458-863_78d6f59d-2648-4d4d-977e-3df83d662e04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
International Laboratories, LLC
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-02-01
Marketing end
0000-00-00
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54458-863-102023-01-30C16284748780-1f386c649-9aef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991
54458-863-162023-01-30C16284748780-1f386c649-9aef-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, film coated for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54458-863-10Benazepril Hydrochloride30 in 1 BLISTER PACKTABLET, COATED3010
54458-863-16Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54458-863-10EA - Each54458-863a062b8a6-e7f9-453b-9e64-fda6e3a8789612016-04-04
54458-863-16EA - Each54458-8633e33f46a-2948-48e7-a895-1380c8bba3c912017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54458-863BENAZEPRIL HYDROCHLORIDE TABLET, COATED [INTERNATIONAL LABORATORIES, LLC]10Legacy NDC, 2 package rows20191219_b454cc1f-58ab-4b21-ae02-e06ec626b9d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSNb454cc1f-58ab-4b21-ae02-e06ec626b9d610
898719benazepril HCl 40 MG Oral TabletPSNb454cc1f-58ab-4b21-ae02-e06ec626b9d610
898690benazepril hydrochloride 20 MG Oral TabletSCDb454cc1f-58ab-4b21-ae02-e06ec626b9d610
898719benazepril hydrochloride 40 MG Oral TabletSCDb454cc1f-58ab-4b21-ae02-e06ec626b9d610
898690BZP hydrochloride 20 MG Oral TabletSYb454cc1f-58ab-4b21-ae02-e06ec626b9d610
898719BZP hydrochloride 40 MG Oral TabletSYb454cc1f-58ab-4b21-ae02-e06ec626b9d610

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54458-863-105445808631030 TABLET, COATED in 1 BLISTER PACK (54458-863-10) 2014-02-010000-00-00NoNoCurrent
54458-863-165445808631630 TABLET, COATED in 1 BOTTLE (54458-863-16) 2017-04-130000-00-00NoNoCurrent