FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
50090-3359
11-digit product format
500903359
Labeler code
50090
Product ID
50090-3359_4a6b0e09-3f06-4d54-8ea6-ce8e130f37d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078212
Marketing category
ANDA
Marketing start
2008-05-22
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
40 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898719

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
50090-3359-02023-02-07C16284748780-1f386c64a-3268-0266-e053-dadaa90a7c1aThese 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
50090-3359-12023-02-07C16284748780-1f386c64a-3268-0266-e053-dadaa90a7c1aThese 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
50090-3359-02023-01-30C16284748780-1f386c64a-3268-0266-e053-dadaa90a7c1aThese 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
50090-3359-12023-01-30C16284748780-1f386c64a-3268-0266-e053-dadaa90a7c1aThese 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
50090-3359-0Benazepril Hydrochloride30 in 1 BOTTLETABLET, FILM COATED305
50090-3359-1Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3359-0EA - Each50090-335902366247-ebd1-4669-a3b6-e3f5390de9ef12019-05-02
50090-3359-1EA - Each50090-335912bc33c0-1403-4c4a-8ee6-7775e67e1c9e12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3359BENAZEPRIL HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20230208_c5090372-41bf-4677-b198-97fd55a0cb87.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSNc5090372-41bf-4677-b198-97fd55a0cb875
898719benazepril hydrochloride 40 MG Oral TabletSCDc5090372-41bf-4677-b198-97fd55a0cb875
898719BZP hydrochloride 40 MG Oral TabletSYc5090372-41bf-4677-b198-97fd55a0cb875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3359-05009033590030 TABLET, FILM COATED in 1 BOTTLE (50090-3359-0) 2018-03-260000-00-00NoNoCurrent
50090-3359-15009033590190 TABLET, FILM COATED in 1 BOTTLE (50090-3359-1) 2018-02-020000-00-00NoNoCurrent