FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
68788-9327
11-digit product format
687889327
Labeler code
68788
Product ID
68788-9327_8478f6f8-1af5-4750-a387-84d322953017
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA076118
Marketing category
ANDA
Marketing start
2015-03-25
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 898690

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
68788-9327-1Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED10014
68788-9327-3Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3014
68788-9327-6Benazepril Hydrochloride60 in 1 BOTTLETABLET, COATED6014
68788-9327-9Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED9014

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9327BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 4 package rows20250126_032ea0f7-3304-4778-b3a6-6125ea7537ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN032ea0f7-3304-4778-b3a6-6125ea7537ab14
898690benazepril HCl 20 MG Oral TabletPSN032ea0f7-3304-4778-b3a6-6125ea7537ab14
898687benazepril hydrochloride 10 MG Oral TabletSCD032ea0f7-3304-4778-b3a6-6125ea7537ab14
898690benazepril hydrochloride 20 MG Oral TabletSCD032ea0f7-3304-4778-b3a6-6125ea7537ab14
898687BZP hydrochloride 10 MG Oral TabletSY032ea0f7-3304-4778-b3a6-6125ea7537ab14
898690BZP hydrochloride 20 MG Oral TabletSY032ea0f7-3304-4778-b3a6-6125ea7537ab14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-9327-168788932701100 TABLET, COATED in 1 BOTTLE (68788-9327-1) 2015-03-250000-00-00NoNoCurrent
68788-9327-36878893270330 TABLET, COATED in 1 BOTTLE (68788-9327-3) 2015-03-250000-00-00NoNoCurrent
68788-9327-66878893270660 TABLET, COATED in 1 BOTTLE (68788-9327-6) 2015-03-250000-00-00NoNoCurrent
68788-9327-96878893270990 TABLET, COATED in 1 BOTTLE (68788-9327-9) 2015-03-250000-00-00NoNoCurrent