FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
50090-3775
11-digit product format
500903775
Labeler code
50090
Product ID
50090-3775_47e4a35d-5bf0-4098-a64b-345b5a87e454
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3775-02023-02-06C16284748780-1f386c649-a704-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-3775-22023-02-06C16284748780-1f386c649-a704-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-3775-02023-01-30C16284748780-1f386c649-a704-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991
50090-3775-22023-01-30C16284748780-1f386c649-a704-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use BENAZEPRIL HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for use BENAZEPRIL HYDROCHLORIDE TABLETS. BENAZEPRIL HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3775-0Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3015
50090-3775-2Benazepril Hydrochloride90 in 1 BOTTLETABLET, COATED9015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3775-0EA - Each50090-3775b7be8d75-1cdf-4ddd-bb92-792f5e0b4b0d12021-10-08
50090-3775-2EA - Each50090-3775faf858fc-5244-47bf-a07e-406a3aa2fb5312021-10-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSN6c24bb4c-42d2-483a-b33f-95182b32b93d15
898687benazepril hydrochloride 10 MG Oral TabletSCD6c24bb4c-42d2-483a-b33f-95182b32b93d15
898687BZP hydrochloride 10 MG Oral TabletSY6c24bb4c-42d2-483a-b33f-95182b32b93d15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3775-05009037750030 TABLET, COATED in 1 BOTTLE (50090-3775-0) 2018-11-050000-00-00NoNoCurrent
50090-3775-25009037750290 TABLET, COATED in 1 BOTTLE (50090-3775-2) 2018-11-050000-00-00NoNoCurrent