FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
43063-679
11-digit product format
430630679
Labeler code
43063
Product ID
43063-679_2fb065bb-3ffc-7a24-e063-6294a90a7352
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
10 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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687

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
43063-679-30Benazepril Hydrochloride30 in 1 BOTTLE, PLASTICTABLET, COATED3020
43063-679-90Benazepril Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-679-30EA - Each43063-679bab2727a-34dd-434c-9013-5ee66225b87312020-05-08
43063-679-90EA - Each43063-6796d4c984d-3449-478b-8286-03b8f5b9172a12020-05-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-679BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PD-RX PHARMACEUTICALS, INC.]20Current NDC, Legacy NDC, 2 package rows20250309_355811f0-2885-0d49-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN355811f0-2885-0d49-e054-00144ff8d46c20
898687benazepril hydrochloride 10 MG Oral TabletSCD355811f0-2885-0d49-e054-00144ff8d46c20
898687BZP hydrochloride 10 MG Oral TabletSY355811f0-2885-0d49-e054-00144ff8d46c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-679-304306306793030 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-679-30) 2016-06-090000-00-00NoNoCurrent
43063-679-904306306799090 TABLET, COATED in 1 BOTTLE, PLASTIC (43063-679-90) 2024-06-070000-00-00NoNoCurrent