FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
65162-754
11-digit product format
651620754
Labeler code
65162
Product ID
65162-754_1897ce48-56e1-415f-9db3-224c48b3063e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
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
Rxcui898687, 898690, 898719, 898723

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
65162-754-03Benazepril Hydrochloride30 in 1 BOTTLETABLET3020
65162-754-10Benazepril Hydrochloride100 in 1 BOTTLETABLET10020
65162-754-50Benazepril Hydrochloride500 in 1 BOTTLETABLET50020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-754BENAZEPRIL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS LLC]20Current NDC, Legacy NDC, 3 package rows20241025_a216253b-27cb-42ef-b5a8-67fb05aafb88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSNb9de06f1-ed65-4962-affb-da8df786553f100
898719benazepril hydrochloride 40 MG Oral TabletSCDb9de06f1-ed65-4962-affb-da8df786553f100
898719BZP hydrochloride 40 MG Oral TabletSYb9de06f1-ed65-4962-affb-da8df786553f100
898687benazepril HCl 10 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898690benazepril HCl 20 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898719benazepril HCl 40 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723benazepril HCl 5 MG Oral TabletPSNa216253b-27cb-42ef-b5a8-67fb05aafb8820
898687benazepril hydrochloride 10 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898690benazepril hydrochloride 20 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898719benazepril hydrochloride 40 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723benazepril hydrochloride 5 MG Oral TabletSCDa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723benazepril HCl 5 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898687BZP hydrochloride 10 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898690BZP hydrochloride 20 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898719BZP hydrochloride 40 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898723BZP hydrochloride 5 MG Oral TabletSYa216253b-27cb-42ef-b5a8-67fb05aafb8820
898687benazepril HCl 10 MG Oral TabletPSNc7b69325-95ba-48bd-b88e-2190f02413371
898690benazepril HCl 20 MG Oral TabletPSNc7b69325-95ba-48bd-b88e-2190f02413371
898719benazepril HCl 40 MG Oral TabletPSNc7b69325-95ba-48bd-b88e-2190f02413371
898687benazepril hydrochloride 10 MG Oral TabletSCDc7b69325-95ba-48bd-b88e-2190f02413371
898690benazepril hydrochloride 20 MG Oral TabletSCDc7b69325-95ba-48bd-b88e-2190f02413371
898719benazepril hydrochloride 40 MG Oral TabletSCDc7b69325-95ba-48bd-b88e-2190f02413371
898687BZP hydrochloride 10 MG Oral TabletSYc7b69325-95ba-48bd-b88e-2190f02413371
898690BZP hydrochloride 20 MG Oral TabletSYc7b69325-95ba-48bd-b88e-2190f02413371
898719BZP hydrochloride 40 MG Oral TabletSYc7b69325-95ba-48bd-b88e-2190f02413371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-754-036516207540330 TABLET in 1 BOTTLE (65162-754-03) 30 tablet2010-02-020000-00-00NoNoCurrent
65162-754-1065162075410100 TABLET in 1 BOTTLE (65162-754-10) 100 tablet2010-02-020000-00-00NoNoCurrent
65162-754-5065162075450500 TABLET in 1 BOTTLE (65162-754-50) 500 tablet2010-02-020000-00-00NoNoCurrent