FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
71335-0078
11-digit product format
713350078
Labeler code
71335
Product ID
71335-0078_c561231e-6648-43dc-a435-ac40c8b4cc1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
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
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898690

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0078-1Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED30103
71335-0078-2Benazepril Hydrochloride60 in 1 BOTTLETABLET, COATED60103
71335-0078-3Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED100103
71335-0078-4Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED90103
71335-0078-5Benazepril Hydrochloride14 in 1 BOTTLETABLET, COATED14103
71335-0078-6Benazepril Hydrochloride10 in 1 BOTTLETABLET, COATED10103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0078BENAZEPRIL HYDROCHLORIDE TABLET, COATED [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 6 package rows20240823_0653322d-70c6-45f7-a9d1-41efee1d7387.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN0653322d-70c6-45f7-a9d1-41efee1d7387103
898690benazepril hydrochloride 20 MG Oral TabletSCD0653322d-70c6-45f7-a9d1-41efee1d7387103
898690BZP hydrochloride 20 MG Oral TabletSY0653322d-70c6-45f7-a9d1-41efee1d7387103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0078-17133500780130 TABLET, COATED in 1 BOTTLE (71335-0078-1) 2022-02-090000-00-00NoNoCurrent
71335-0078-27133500780260 TABLET, COATED in 1 BOTTLE (71335-0078-2) 2022-02-090000-00-00NoNoCurrent
71335-0078-371335007803100 TABLET, COATED in 1 BOTTLE (71335-0078-3) 2022-02-090000-00-00NoNoCurrent
71335-0078-47133500780490 TABLET, COATED in 1 BOTTLE (71335-0078-4) 2022-02-090000-00-00NoNoCurrent
71335-0078-57133500780514 TABLET, COATED in 1 BOTTLE (71335-0078-5) 2022-02-090000-00-00NoNoCurrent
71335-0078-67133500780610 TABLET, COATED in 1 BOTTLE (71335-0078-6) 2022-02-090000-00-00NoNoCurrent