FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
50090-0913
11-digit product format
500900913
Labeler code
50090
Product ID
50090-0913_4bc98cf5-c8e4-4db7-9f99-b63980edc7e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
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
2022-12-31
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
50090-0913-02023-01-30C16284748780-1f386c649-c4ce-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991
50090-0913-12023-01-30C16284748780-1f386c649-c4ce-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HCl TABLETS safely and effectively. See full prescribing information for BENAZEPRIL HCl TABLETS. BENAZEPRIL HCl tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0913-0Benazepril Hydrochloride30 in 1 BOTTLETABLET3014
50090-0913-1Benazepril Hydrochloride90 in 1 BOTTLETABLET9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0913-0EA - Each50090-0913ff56c127-3933-4218-9def-5f6c3923a06c12018-10-11
50090-0913-1EA - Each50090-091339f213b0-27c8-47ee-aa81-2a68bdafe78712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0913BENAZEPRIL HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS]14Legacy NDC, 2 package rows20210616_a1c00243-18b4-40fe-ac1e-2cff4ee0d7f1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSNa1c00243-18b4-40fe-ac1e-2cff4ee0d7f114
898690benazepril hydrochloride 20 MG Oral TabletSCDa1c00243-18b4-40fe-ac1e-2cff4ee0d7f114
898690BZP hydrochloride 20 MG Oral TabletSYa1c00243-18b4-40fe-ac1e-2cff4ee0d7f114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0913-05009009130030 TABLET in 1 BOTTLE (50090-0913-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0913-15009009130190 TABLET in 1 BOTTLE (50090-0913-1) 90 tablet2014-11-280000-00-00NoNoCurrent