FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
63187-500
11-digit product format
631870500
Labeler code
63187
Product ID
63187-500_8b462d0b-fe6e-4240-abd2-2eafbf58a98d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 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
63187-500-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED306
63187-500-60Benazepril Hydrochloride60 in 1 BOTTLETABLET, COATED606
63187-500-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED906

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-500BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20240109_ebdf5144-752d-456f-b46d-19cbba0bc3d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNebdf5144-752d-456f-b46d-19cbba0bc3d76
898723benazepril HCl 5 MG Oral TabletPSNebdf5144-752d-456f-b46d-19cbba0bc3d76
898687benazepril hydrochloride 10 MG Oral TabletSCDebdf5144-752d-456f-b46d-19cbba0bc3d76
898723benazepril hydrochloride 5 MG Oral TabletSCDebdf5144-752d-456f-b46d-19cbba0bc3d76
898723benazepril HCl 5 MG Oral TabletSYebdf5144-752d-456f-b46d-19cbba0bc3d76
898687BZP hydrochloride 10 MG Oral TabletSYebdf5144-752d-456f-b46d-19cbba0bc3d76
898723BZP hydrochloride 5 MG Oral TabletSYebdf5144-752d-456f-b46d-19cbba0bc3d76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-500-306318705003030 TABLET, COATED in 1 BOTTLE (63187-500-30) 2015-02-020000-00-00NoNoCurrent
63187-500-606318705006060 TABLET, COATED in 1 BOTTLE (63187-500-60) 2015-02-020000-00-00NoNoCurrent
63187-500-906318705009090 TABLET, COATED in 1 BOTTLE (63187-500-90) 2015-02-020000-00-00NoNoCurrent