FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
65862-117
11-digit product format
658620117
Labeler code
65862
Product ID
65862-117_0e5c3b12-afaa-4816-9af8-ebf2363dcef2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078212
Marketing category
ANDA
Marketing start
2008-05-22
Marketing end
2026-11-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 898690, 898719

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
65862-117-01Benazepril Hydrochloride100 in 1 BOTTLETABLET, FILM COATED10026
65862-117-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED9026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-117-01EA - Each65862-11786c602df-4e5f-444c-a13d-0cb30af30e7912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-117BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]25Current NDC, Legacy NDC, 2 package rows20240509_09e383a8-e912-4cf7-8fb3-05545af80dd0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN09e383a8-e912-4cf7-8fb3-05545af80dd026
898690benazepril HCl 20 MG Oral TabletPSN09e383a8-e912-4cf7-8fb3-05545af80dd026
898719benazepril HCl 40 MG Oral TabletPSN09e383a8-e912-4cf7-8fb3-05545af80dd026
898687benazepril hydrochloride 10 MG Oral TabletSCD09e383a8-e912-4cf7-8fb3-05545af80dd026
898690benazepril hydrochloride 20 MG Oral TabletSCD09e383a8-e912-4cf7-8fb3-05545af80dd026
898719benazepril hydrochloride 40 MG Oral TabletSCD09e383a8-e912-4cf7-8fb3-05545af80dd026
898687BZP hydrochloride 10 MG Oral TabletSY09e383a8-e912-4cf7-8fb3-05545af80dd026
898690BZP hydrochloride 20 MG Oral TabletSY09e383a8-e912-4cf7-8fb3-05545af80dd026
898719BZP hydrochloride 40 MG Oral TabletSY09e383a8-e912-4cf7-8fb3-05545af80dd026
898690benazepril HCl 20 MG Oral TabletPSNe0d5362b-f5da-4838-ae91-22f40fcca2455
898690benazepril hydrochloride 20 MG Oral TabletSCDe0d5362b-f5da-4838-ae91-22f40fcca2455
898690BZP hydrochloride 20 MG Oral TabletSYe0d5362b-f5da-4838-ae91-22f40fcca2455
898690benazepril HCl 20 MG Oral TabletPSNfc4cd253-13ee-9424-e053-6394a90a35a82
898690benazepril hydrochloride 20 MG Oral TabletSCDfc4cd253-13ee-9424-e053-6394a90a35a82
898690BZP hydrochloride 20 MG Oral TabletSYfc4cd253-13ee-9424-e053-6394a90a35a82
898690benazepril HCl 20 MG Oral TabletPSNf40f15a9-c3bc-7040-e053-2995a90a0bab1
898690benazepril hydrochloride 20 MG Oral TabletSCDf40f15a9-c3bc-7040-e053-2995a90a0bab1
898690BZP hydrochloride 20 MG Oral TabletSYf40f15a9-c3bc-7040-e053-2995a90a0bab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-117-0165862011701100 TABLET, FILM COATED in 1 BOTTLE (65862-117-01) 2008-05-222026-11-30NoNoCurrent
65862-117-906586201179090 TABLET, FILM COATED in 1 BOTTLE (65862-117-90) 2008-05-220000-00-00NoNoCurrent