Benazepril Hydrochloride

Product NDC
63304-738
11-digit product format
633040738
Labeler code
63304
Product ID
63304-738_f24643e9-a2bc-47f0-9e4c-4214d5464323
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benazepril hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ranbaxy Pharmaceuticals Inc.
Application
ANDA076344
Marketing category
ANDA
Marketing start
2004-02-11
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
E
Listing certified through
2018-12-31
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
63304-738-102020-01-31C16284748780-19d75b9d0-9db7-f424-e053-dadaa90a57ceRx only
63304-738-302020-01-31C16284748780-19d75b9d0-9db7-f424-e053-dadaa90a57ceRx only
63304-738-772020-01-31C16284748780-19d75b9d0-9db7-f424-e053-dadaa90a57ceRx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63304-738-10Benazepril Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004
63304-738-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
63304-738-77Benazepril Hydrochloride100 in 1 BLISTER PACKTABLET, FILM COATED1004

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63304-738BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.]4Legacy NDC, 3 package rows20150430_6f422de2-3f97-4d25-a5f0-a21225e59036.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN6f422de2-3f97-4d25-a5f0-a21225e590364
898690benazepril HCl 20 MG Oral TabletPSN6f422de2-3f97-4d25-a5f0-a21225e590364
898719benazepril HCl 40 MG Oral TabletPSN6f422de2-3f97-4d25-a5f0-a21225e590364
898723benazepril HCl 5 MG Oral TabletPSN6f422de2-3f97-4d25-a5f0-a21225e590364
898687benazepril hydrochloride 10 MG Oral TabletSCD6f422de2-3f97-4d25-a5f0-a21225e590364
898690benazepril hydrochloride 20 MG Oral TabletSCD6f422de2-3f97-4d25-a5f0-a21225e590364
898719benazepril hydrochloride 40 MG Oral TabletSCD6f422de2-3f97-4d25-a5f0-a21225e590364
898723benazepril hydrochloride 5 MG Oral TabletSCD6f422de2-3f97-4d25-a5f0-a21225e590364
898723benazepril HCl 5 MG Oral TabletSY6f422de2-3f97-4d25-a5f0-a21225e590364
898687BZP hydrochloride 10 MG Oral TabletSY6f422de2-3f97-4d25-a5f0-a21225e590364
898690BZP hydrochloride 20 MG Oral TabletSY6f422de2-3f97-4d25-a5f0-a21225e590364
898719BZP hydrochloride 40 MG Oral TabletSY6f422de2-3f97-4d25-a5f0-a21225e590364
898723BZP hydrochloride 5 MG Oral TabletSY6f422de2-3f97-4d25-a5f0-a21225e590364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
63304-738-10633040738101000 in 1 BOTTLEHistorical
63304-738-306330407383030 in 1 BOTTLEHistorical
63304-738-7763304073877100 in 1 BLISTER PACKHistorical