FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
71335-0854
11-digit product format
713350854
Labeler code
71335
Product ID
71335-0854_a518664a-2636-475f-824b-81cc1e710c78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076820
Marketing category
ANDA
Marketing start
2010-02-02
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
71335-0854-1Benazepril Hydrochloride30 in 1 BOTTLETABLET3011
71335-0854-2Benazepril Hydrochloride60 in 1 BOTTLETABLET6011
71335-0854-3Benazepril Hydrochloride100 in 1 BOTTLETABLET10011
71335-0854-4Benazepril Hydrochloride90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0854-1EA - Each71335-08542834a3f4-058c-4602-b31b-22c7877d6cad12020-09-14
71335-0854-4EA - Each71335-0854b248f144-79de-4ac5-a391-aa02b69db39312020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0854BENAZEPRIL HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]11Current NDC, Legacy NDC, 4 package rows20231128_cd1a7c8f-cc61-4ee4-a259-0b3329cced3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNcd1a7c8f-cc61-4ee4-a259-0b3329cced3e11
898687benazepril hydrochloride 10 MG Oral TabletSCDcd1a7c8f-cc61-4ee4-a259-0b3329cced3e11
898687BZP hydrochloride 10 MG Oral TabletSYcd1a7c8f-cc61-4ee4-a259-0b3329cced3e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0854-17133508540130 TABLET in 1 BOTTLE (71335-0854-1) 30 tablet2018-08-170000-00-00NoNoCurrent
71335-0854-27133508540260 TABLET in 1 BOTTLE (71335-0854-2) 60 tablet2022-03-090000-00-00NoNoCurrent
71335-0854-371335085403100 TABLET in 1 BOTTLE (71335-0854-3) 100 tablet2022-04-110000-00-00NoNoCurrent
71335-0854-47133508540490 TABLET in 1 BOTTLE (71335-0854-4) 90 tablet2018-06-110000-00-00NoNoCurrent