Benazepril Hydrochloride

Product NDC
45865-747
11-digit product format
458650747
Labeler code
45865
Product ID
45865-747_1ff68ace-8d62-64f5-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-747-302020-01-31C16284748780-19d75b9d0-4daa-f424-e053-dadaa90a57ceBenazepril Hydrochloride Tablets, USP, film coated for oral use

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-747-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED301

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-747BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20150917_1ff68ace-8d61-64f5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN1ff68ace-8d61-64f5-e054-00144ff88e881
898690benazepril hydrochloride 20 MG Oral TabletSCD1ff68ace-8d61-64f5-e054-00144ff88e881
898690BZP hydrochloride 20 MG Oral TabletSY1ff68ace-8d61-64f5-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-747-304586507473030 in 1 BOTTLEHistorical