FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
70518-2125
11-digit product format
705182125
Labeler code
70518
Product ID
70518-2125_49a0827c-f0bd-2aa2-e063-6394a90abb0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076118
Marketing category
ANDA
Marketing start
2019-05-31
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
40 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 HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898719

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
70518-2125-02023-03-07C16284748780-1f386c649-e6ba-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
70518-2125-02023-03-07C16284748780-1f386c649-e6ba-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
70518-2125-12023-03-07C16284748780-1f386c649-e6ba-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
70518-2125-12023-03-07C16284748780-1f386c649-e6ba-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
70518-2125-02023-01-30C16284748780-1f386c649-e6ba-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
70518-2125-02023-01-30C16284748780-1f386c649-e6ba-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
70518-2125-12023-01-30C16284748780-1f386c649-e6ba-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
70518-2125-12023-01-30C16284748780-1f386c649-e6ba-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
70518-2125-0Benazepril Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, COATED9011
70518-2125-1Benazepril Hydrochloride30 in 1 BLISTER PACKTABLET, COATED3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2125-0EA - Each70518-21250d780f62-b428-47af-90d6-1516fafc770012024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2125BENAZEPRIL HYDROCHLORIDE TABLET, COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 2 package rows20250308_afd616b9-0c75-48be-862d-5ac18364fd9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898719benazepril HCl 40 MG Oral TabletPSNafd616b9-0c75-48be-862d-5ac18364fd9d11
898719benazepril hydrochloride 40 MG Oral TabletSCDafd616b9-0c75-48be-862d-5ac18364fd9d11
898719BZP hydrochloride 40 MG Oral TabletSYafd616b9-0c75-48be-862d-5ac18364fd9d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2125-07051821250090 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-2125-0) 2019-05-310000-00-00NoNoCurrent
70518-2125-17051821250130 TABLET, COATED in 1 BLISTER PACK (70518-2125-1) 2020-06-080000-00-00NoNoCurrent