FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
71335-1086
11-digit product format
713351086
Labeler code
71335
Product ID
71335-1086_fc9d1bd9-f945-7c61-e053-6294a90a3117
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
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
71335-1086-1Benazepril Hydrochloride30 in 1 BOTTLETABLET30101
71335-1086-2Benazepril Hydrochloride60 in 1 BOTTLETABLET60101
71335-1086-3Benazepril Hydrochloride100 in 1 BOTTLETABLET100101
71335-1086-4Benazepril Hydrochloride90 in 1 BOTTLETABLET90101
71335-1086-5Benazepril Hydrochloride14 in 1 BOTTLETABLET14101
71335-1086-6Benazepril Hydrochloride10 in 1 BOTTLETABLET10101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1086BENAZEPRIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 6 package rows20230603_2b02c240-4393-48ed-a385-561ced7b7abf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN2b02c240-4393-48ed-a385-561ced7b7abf101
898690benazepril hydrochloride 20 MG Oral TabletSCD2b02c240-4393-48ed-a385-561ced7b7abf101
898690BZP hydrochloride 20 MG Oral TabletSY2b02c240-4393-48ed-a385-561ced7b7abf101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1086-17133510860130 TABLET in 1 BOTTLE (71335-1086-1) 30 tablet2022-05-040000-00-00NoNoCurrent
71335-1086-27133510860260 TABLET in 1 BOTTLE (71335-1086-2) 60 tablet2022-05-040000-00-00NoNoCurrent
71335-1086-371335108603100 TABLET in 1 BOTTLE (71335-1086-3) 100 tablet2022-05-040000-00-00NoNoCurrent
71335-1086-47133510860490 TABLET in 1 BOTTLE (71335-1086-4) 90 tablet2022-05-040000-00-00NoNoCurrent
71335-1086-57133510860514 TABLET in 1 BOTTLE (71335-1086-5) 14 tablet2022-05-040000-00-00NoNoCurrent
71335-1086-67133510860610 TABLET in 1 BOTTLE (71335-1086-6) 10 tablet2022-05-040000-00-00NoNoCurrent