FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
53002-1248
11-digit product format
530021248
Labeler code
53002
Product ID
53002-1248_e05ed176-893d-47d3-a0ba-9f643e335479
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
10 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
2021-12-31
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
53002-1248-02025-01-30C16284748780-1f386c649-d3a2-0266-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
53002-1248-02023-06-07C16284748780-1f386c649-d3a2-0266-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
53002-1248-02023-01-30C16284748780-1f386c649-d3a2-0266-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
53002-1248-0Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1248BENAZEPRIL HYDROCHLORIDE TABLET, COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20230609_24ea205e-9993-429e-9df6-f4163d21312c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN24ea205e-9993-429e-9df6-f4163d21312c3
898687benazepril hydrochloride 10 MG Oral TabletSCD24ea205e-9993-429e-9df6-f4163d21312c3
898687BZP hydrochloride 10 MG Oral TabletSY24ea205e-9993-429e-9df6-f4163d21312c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-1248-053002124800100 TABLET, COATED in 1 BOTTLE (53002-1248-0) 2020-01-010000-00-00NoNoCurrent