FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
63187-906
11-digit product format
631870906
Labeler code
63187
Product ID
63187-906_9eeaae93-ac71-4721-98ad-8c7a9231f822
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-906-30Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED305
63187-906-60Benazepril Hydrochloride60 in 1 BOTTLETABLET, COATED605
63187-906-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-906-30EA - Each63187-906cffe9d83-ed83-41bc-9e6b-5139faf554ad12017-11-06
63187-906-90EA - Each63187-906eb09d2dc-664d-4e8a-a327-ac6f4c9f0e6a12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-906BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20230811_313225d7-f947-40b3-96d7-289aad300a4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSN313225d7-f947-40b3-96d7-289aad300a4a5
898719benazepril hydrochloride 40 MG Oral TabletSCD313225d7-f947-40b3-96d7-289aad300a4a5
898719BZP hydrochloride 40 MG Oral TabletSY313225d7-f947-40b3-96d7-289aad300a4a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-906-306318709063030 TABLET, COATED in 1 BOTTLE (63187-906-30) 2017-09-010000-00-00NoNoCurrent
63187-906-606318709066060 TABLET, COATED in 1 BOTTLE (63187-906-60) 2017-09-010000-00-00NoNoCurrent
63187-906-906318709069090 TABLET, COATED in 1 BOTTLE (63187-906-90) 2017-09-010000-00-00NoNoCurrent