FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
63187-393
11-digit product format
631870393
Labeler code
63187
Product ID
63187-393_cac335b0-2fc0-420f-b52a-a7216e940192
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Proficient Rx LP
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
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 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
63187-393-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED304
63187-393-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-393-30EA - Each63187-3932b18a160-5acc-4445-9615-27bd29c9b8e212020-01-03
63187-393-90EA - Each63187-3934992c6df-1639-4fae-a72f-94029c645fe912016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-393BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 2 package rows20240711_be41d21c-4747-47bb-b4b7-bbfabcd7a9b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSNbe41d21c-4747-47bb-b4b7-bbfabcd7a9b14
898690benazepril hydrochloride 20 MG Oral TabletSCDbe41d21c-4747-47bb-b4b7-bbfabcd7a9b14
898690BZP hydrochloride 20 MG Oral TabletSYbe41d21c-4747-47bb-b4b7-bbfabcd7a9b14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-393-306318703933030 TABLET, COATED in 1 BOTTLE (63187-393-30) 2016-09-010000-00-00NoNoCurrent
63187-393-606318703936060 TABLET, COATED in 1 BOTTLE (63187-393-60) 2016-09-010000-00-00NoNoCurrent
63187-393-906318703939090 TABLET, COATED in 1 BOTTLE (63187-393-90) 2016-09-010000-00-00NoNoCurrent