FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
50436-0337
11-digit product format
504360337
Labeler code
50436
Product ID
50436-0337_9a731f92-6a83-4cf9-bdcf-99d0dc2b15d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
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
50436-0337-32021-01-29C16284748780-1ba0f9c33-4c34-a910-e053-dadaa90a0b85These 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
50436-0337-3Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0337BENAZEPRIL HYDROCHLORIDE TABLET, COATED [UNIT DOSE SERVICES]2Legacy NDC, 1 package rows20180929_48aadb84-1468-4cee-b566-f9b1c6fd4403.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN48aadb84-1468-4cee-b566-f9b1c6fd44032
898690benazepril hydrochloride 20 MG Oral TabletSCD48aadb84-1468-4cee-b566-f9b1c6fd44032
898690BZP hydrochloride 20 MG Oral TabletSY48aadb84-1468-4cee-b566-f9b1c6fd44032

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0337-35043603370390 in 1 BOTTLEHistorical