FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
53746-752
11-digit product format
537460752
Labeler code
53746
Product ID
53746-752_e8e7c1c3-9bd1-4752-9ad9-da0a73c12a0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals of New York LLC
Application
ANDA076820
Marketing category
ANDA
Marketing start
2022-09-26
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
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 HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T
Rxcui898687, 898690, 898719, 898723

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
53746-752-01Benazepril Hydrochloride100 in 1 BOTTLETABLET1004
53746-752-05Benazepril Hydrochloride500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53746-752-01EA - Each53746-752a59a7b4e-b1eb-47d9-b7a1-719a5054f8c712023-03-13
53746-752-05EA - Each53746-752322c7600-5945-40a1-bea1-45ed706ec34e12023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Anhydrous LactoseINACTIVE INGREDIENT3SY5LH9PMKBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
CrospovidoneINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2
TalcINACTIVE INGREDIENT7SEV7J4R1UBENAZEPRIL HYDROCHLORIDE TABLET [AVPAK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53746-752BENAZEPRIL HYDROCHLORIDE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC]2Current NDC, Legacy NDC, 2 package rows20240101_e0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898690benazepril HCl 20 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898719benazepril HCl 40 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723benazepril HCl 5 MG Oral TabletPSNf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898687benazepril hydrochloride 10 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898690benazepril hydrochloride 20 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898719benazepril hydrochloride 40 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723benazepril hydrochloride 5 MG Oral TabletSCDf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723benazepril HCl 5 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898687BZP hydrochloride 10 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898690BZP hydrochloride 20 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898719BZP hydrochloride 40 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898723BZP hydrochloride 5 MG Oral TabletSYf004d7e2-fc45-8a37-e548-eeaaa327f9b511
898687benazepril HCl 10 MG Oral TabletPSNe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898690benazepril HCl 20 MG Oral TabletPSNe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898719benazepril HCl 40 MG Oral TabletPSNe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898723benazepril HCl 5 MG Oral TabletPSNe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898687benazepril hydrochloride 10 MG Oral TabletSCDe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898690benazepril hydrochloride 20 MG Oral TabletSCDe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898719benazepril hydrochloride 40 MG Oral TabletSCDe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898723benazepril hydrochloride 5 MG Oral TabletSCDe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898723benazepril HCl 5 MG Oral TabletSYe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898687BZP hydrochloride 10 MG Oral TabletSYe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898690BZP hydrochloride 20 MG Oral TabletSYe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898719BZP hydrochloride 40 MG Oral TabletSYe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4
898723BZP hydrochloride 5 MG Oral TabletSYe0ddcfbc-c9d8-45b1-9c11-0d1eff8c1e9e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53746-752-0153746075201100 TABLET in 1 BOTTLE (53746-752-01) 100 tablet2022-09-260000-00-00NoNoCurrent
53746-752-0553746075205500 TABLET in 1 BOTTLE (53746-752-05) 500 tablet2022-09-260000-00-00NoNoCurrent