FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
68071-5028
11-digit product format
680715028
Labeler code
68071
Product ID
68071-5028_1b40dd04-e68e-bf64-e063-6294a90a43db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA078212
Marketing category
ANDA
Marketing start
2008-05-22
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898719

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
68071-5028-12024-06-19C16284748780-1ba0f9c33-469e-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, for oral use Initial U.S. Approval: 1991
68071-5028-12023-01-30C16284748780-1ba0f9c33-469e-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, for oral use Initial U.S. Approval: 1991
68071-5028-12021-02-19C16284748780-1ba0f9c33-469e-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, for oral use Initial U.S. Approval: 1991
68071-5028-12021-01-29C16284748780-1ba0f9c33-469e-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, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5028-1Benazepril Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5028BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240620_9016634a-1bdd-700d-e053-2995a90a8f27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSN9016634a-1bdd-700d-e053-2995a90a8f273
898719benazepril hydrochloride 40 MG Oral TabletSCD9016634a-1bdd-700d-e053-2995a90a8f273
898719BZP hydrochloride 40 MG Oral TabletSY9016634a-1bdd-700d-e053-2995a90a8f273

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5028-168071502801100 TABLET, FILM COATED in 1 BOTTLE (68071-5028-1) 2019-08-140000-00-00NoNoCurrent