Benazepril Hydrochloride

Product NDC
84386-101
11-digit product format
843860101
Labeler code
84386
Product ID
84386-101_67c64de1-5579-46e4-82ee-c9bbee708e02
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078212
Marketing category
ANDA
Marketing start
2026-01-13
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Benazepril Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 898690, 898719

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
84386-101-01Benazepril Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1001
84386-101-90Benazepril Hydrochloride90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN67c64de1-5579-46e4-82ee-c9bbee708e021
898690benazepril HCl 20 MG Oral TabletPSN67c64de1-5579-46e4-82ee-c9bbee708e021
898719benazepril HCl 40 MG Oral TabletPSN67c64de1-5579-46e4-82ee-c9bbee708e021
898687benazepril hydrochloride 10 MG Oral TabletSCD67c64de1-5579-46e4-82ee-c9bbee708e021
898690benazepril hydrochloride 20 MG Oral TabletSCD67c64de1-5579-46e4-82ee-c9bbee708e021
898719benazepril hydrochloride 40 MG Oral TabletSCD67c64de1-5579-46e4-82ee-c9bbee708e021
898687BZP hydrochloride 10 MG Oral TabletSY67c64de1-5579-46e4-82ee-c9bbee708e021
898690BZP hydrochloride 20 MG Oral TabletSY67c64de1-5579-46e4-82ee-c9bbee708e021
898719BZP hydrochloride 40 MG Oral TabletSY67c64de1-5579-46e4-82ee-c9bbee708e021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84386-101-0184386010101100 TABLET, FILM COATED in 1 BOTTLE (84386-101-01) 2026-01-13NoNoCurrent
84386-101-61843860101616000 TABLET, FILM COATED in 1 BAG (84386-101-61)13-JAN-26Current
84386-101-908438601019090 TABLET, FILM COATED in 1 BOTTLE (84386-101-90) 2026-01-13NoNoCurrent