FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
68788-8877
11-digit product format
687888877
Labeler code
68788
Product ID
68788-8877_91a3d0f7-d2df-4230-ad9e-b32f7312d337
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078212
Marketing category
ANDA
Marketing start
2025-05-19
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
68788-8877-1Benazepril Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
68788-8877-3Benazepril Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
68788-8877-6Benazepril Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601
68788-8877-9Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8877-1EA - Each68788-88774354923b-3137-4856-993c-23c45e9ec6f912025-07-08
68788-8877-3EA - Each68788-8877a8956f7d-47f1-4bef-943b-bd432c9f740b12025-07-08
68788-8877-6EA - Each68788-88772f6705ff-aa6b-4b25-8cdf-84d377abc51612025-07-08
68788-8877-9EA - Each68788-887751f15509-d15d-4623-b214-09f5cb835feb12025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN91a3d0f7-d2df-4230-ad9e-b32f7312d3371
898687benazepril hydrochloride 10 MG Oral TabletSCD91a3d0f7-d2df-4230-ad9e-b32f7312d3371
898687BZP hydrochloride 10 MG Oral TabletSY91a3d0f7-d2df-4230-ad9e-b32f7312d3371

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8877-168788887701100 TABLET, FILM COATED in 1 BOTTLE (68788-8877-1) 2025-05-19NoNoCurrent
68788-8877-36878888770330 TABLET, FILM COATED in 1 BOTTLE (68788-8877-3) 2025-05-19NoNoCurrent
68788-8877-66878888770660 TABLET, FILM COATED in 1 BOTTLE (68788-8877-6) 2025-05-19NoNoCurrent
68788-8877-96878888770990 TABLET, FILM COATED in 1 BOTTLE (68788-8877-9) 2025-05-19NoNoCurrent