FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
51655-065
11-digit product format
516550065
Labeler code
51655
Product ID
51655-065_4ab5d5ca-26c4-1c5f-e063-6394a90a00ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA076118
Marketing category
ANDA
Marketing start
2016-06-23
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

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
51655-065-262026-01-29C16284748780-19d75b9d0-15c4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
51655-065-522026-01-29C16284748780-19d75b9d0-15c4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
51655-065-522023-02-17C16284748780-19d75b9d0-15c4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
51655-065-522020-01-31C16284748780-19d75b9d0-15c4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-065-26Benazepril Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED904
51655-065-52Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-065BENAZEPRIL HYDROCHLORIDE TABLET, COATED [NORTHWIND PHARMACEUTICALS]2Current NDC, Legacy NDC, 2 package rows20230217_3631d1dc-45e1-0588-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN3631d1dc-45e1-0588-e054-00144ff88e884
898687benazepril hydrochloride 10 MG Oral TabletSCD3631d1dc-45e1-0588-e054-00144ff88e884
898687BZP hydrochloride 10 MG Oral TabletSY3631d1dc-45e1-0588-e054-00144ff88e884

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-065-265165500652690 TABLET, COATED in 1 BOTTLE, PLASTIC (51655-065-26) 2022-05-27NoNoHistorical
51655-065-525165500655230 TABLET, COATED in 1 BOTTLE (51655-065-52) 2016-06-23NoNoHistorical