FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
43063-677
11-digit product format
430630677
Labeler code
43063
Product ID
43063-677_2fb04f78-5c4d-59d2-e063-6294a90a4b8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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
43063-677-30Benazepril Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, COATED3018
43063-677-90Benazepril Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-677-30EA - Each43063-67791e52fdc-a8c8-4710-9e4d-eda5de181bed12020-05-08
43063-677-90EA - Each43063-677334cc3f6-768f-48f6-8179-7e4e1335d58f12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-677BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20250309_1a7b373a-9b74-4b9d-93fb-081614222e30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898690benazepril HCl 20 MG Oral TabletPSN1a7b373a-9b74-4b9d-93fb-081614222e3018
898690benazepril hydrochloride 20 MG Oral TabletSCD1a7b373a-9b74-4b9d-93fb-081614222e3018
898690BZP hydrochloride 20 MG Oral TabletSY1a7b373a-9b74-4b9d-93fb-081614222e3018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-677-304306306773030 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-677-30) 2016-06-090000-00-00NoNoCurrent
43063-677-904306306779090 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-677-90) 2024-06-07NoNoCurrent