FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
50090-3243
11-digit product format
500903243
Labeler code
50090
Product ID
50090-3243_fdee60ff-213d-4b76-8c7b-952cbb037ad9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
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
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 HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898690

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
50090-3243-0Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3017
50090-3243-1Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3243-0EA - Each50090-32435fa4964a-e4e6-450f-bf5c-ca7bade77b9112019-05-02
50090-3243-1EA - Each50090-32433be3fdf9-69dd-4cbf-8fd1-e169a7942aa812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3243BENAZEPRIL HYDROCHLORIDE TABLET, COATED [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 2 package rows20231212_7aac6a2f-85fb-4c7a-b424-9c253186dffe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN7aac6a2f-85fb-4c7a-b424-9c253186dffe17
898690benazepril hydrochloride 20 MG Oral TabletSCD7aac6a2f-85fb-4c7a-b424-9c253186dffe17
898690BZP hydrochloride 20 MG Oral TabletSY7aac6a2f-85fb-4c7a-b424-9c253186dffe17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3243-05009032430030 TABLET, COATED in 1 BOTTLE (50090-3243-0) 2017-11-170000-00-00NoNoCurrent
50090-3243-15009032430190 TABLET, COATED in 1 BOTTLE (50090-3243-1) 2017-11-030000-00-00NoNoCurrent