FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
50268-109
11-digit product format
502680109
Labeler code
50268
Product ID
50268-109_3f7e3955-e107-517a-e063-6294a90a0b13
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA076820
Marketing category
ANDA
Marketing start
2014-04-28
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 898690, 898719, 898723

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
50268-109-11Benazepril Hydrochloride1 in 1 BLISTER PACKTABLET111
50268-109-15Benazepril Hydrochloride50 in 1 BOXTABLET5011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-109-11EA - Each50268-109ac4fecf8-0725-4691-ac80-1ef526c6237412015-04-03
50268-109-15EA - Each50268-109070f951f-e6e0-488e-a022-bf5512baf5f112014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
CrospovidoneINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
TalcINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-109BENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]10Current NDC, Legacy NDC, 2 package rows20230504_f004d7e2-fc45-8a37-e548-eeaaa327f9b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898690benazepril HCl 20 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898719benazepril HCl 40 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723benazepril HCl 5 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898687benazepril hydrochloride 10 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898690benazepril hydrochloride 20 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898719benazepril hydrochloride 40 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723benazepril hydrochloride 5 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723benazepril HCl 5 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898687BZP hydrochloride 10 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898690BZP hydrochloride 20 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898719BZP hydrochloride 40 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723BZP hydrochloride 5 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-109-11502680109111 in 1 BLISTER PACKHistorical
50268-109-155026801091550 BLISTER PACK in 1 BOX (50268-109-15) / 1 TABLET in 1 BLISTER PACK (50268-109-11) 50 blister pack2014-04-280000-00-00NoNoCurrent