FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
43547-335
11-digit product format
435470335
Labeler code
43547
Product ID
43547-335_fc8f15d2-3382-4933-a6bb-b1c57d50d57b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benazepril Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Solco healthcare U.S., LLC
Application
ANDA076118
Marketing category
ANDA
Marketing start
2014-01-01
Substance
BENAZEPRIL HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
43547-335-03Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3011
43547-335-10Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED10011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]3
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-335BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]11Current NDC, Legacy NDC, 2 package rows20241224_bb91223e-ffa5-4a3a-b191-fe121250c20c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNbb91223e-ffa5-4a3a-b191-fe121250c20c11
898690benazepril HCl 20 MG Oral TabletPSNbb91223e-ffa5-4a3a-b191-fe121250c20c11
898719benazepril HCl 40 MG Oral TabletPSNbb91223e-ffa5-4a3a-b191-fe121250c20c11
898723benazepril HCl 5 MG Oral TabletPSNbb91223e-ffa5-4a3a-b191-fe121250c20c11
898687benazepril hydrochloride 10 MG Oral TabletSCDbb91223e-ffa5-4a3a-b191-fe121250c20c11
898690benazepril hydrochloride 20 MG Oral TabletSCDbb91223e-ffa5-4a3a-b191-fe121250c20c11
898719benazepril hydrochloride 40 MG Oral TabletSCDbb91223e-ffa5-4a3a-b191-fe121250c20c11
898723benazepril hydrochloride 5 MG Oral TabletSCDbb91223e-ffa5-4a3a-b191-fe121250c20c11
898723benazepril HCl 5 MG Oral TabletSYbb91223e-ffa5-4a3a-b191-fe121250c20c11
898687BZP hydrochloride 10 MG Oral TabletSYbb91223e-ffa5-4a3a-b191-fe121250c20c11
898690BZP hydrochloride 20 MG Oral TabletSYbb91223e-ffa5-4a3a-b191-fe121250c20c11
898719BZP hydrochloride 40 MG Oral TabletSYbb91223e-ffa5-4a3a-b191-fe121250c20c11
898723BZP hydrochloride 5 MG Oral TabletSYbb91223e-ffa5-4a3a-b191-fe121250c20c11
898723benazepril HCl 5 MG Oral TabletPSNe9a1ae6e-e080-4595-ba0f-0458c1e7e34d9
898723benazepril HCl 5 MG Oral TabletPSN01a3c9f6-41aa-47a7-8c56-5462c6b544169
898723benazepril hydrochloride 5 MG Oral TabletSCDe9a1ae6e-e080-4595-ba0f-0458c1e7e34d9
898723benazepril hydrochloride 5 MG Oral TabletSCD01a3c9f6-41aa-47a7-8c56-5462c6b544169
898723benazepril HCl 5 MG Oral TabletSYe9a1ae6e-e080-4595-ba0f-0458c1e7e34d9
898723benazepril HCl 5 MG Oral TabletSY01a3c9f6-41aa-47a7-8c56-5462c6b544169
898723BZP hydrochloride 5 MG Oral TabletSYe9a1ae6e-e080-4595-ba0f-0458c1e7e34d9
898723BZP hydrochloride 5 MG Oral TabletSY01a3c9f6-41aa-47a7-8c56-5462c6b544169
898687benazepril HCl 10 MG Oral TabletPSNebdf5144-752d-456f-b46d-19cbba0bc3d76
898723benazepril HCl 5 MG Oral TabletPSNebdf5144-752d-456f-b46d-19cbba0bc3d76
898687benazepril hydrochloride 10 MG Oral TabletSCDebdf5144-752d-456f-b46d-19cbba0bc3d76
898723benazepril hydrochloride 5 MG Oral TabletSCDebdf5144-752d-456f-b46d-19cbba0bc3d76
898723benazepril HCl 5 MG Oral TabletSYebdf5144-752d-456f-b46d-19cbba0bc3d76
898687BZP hydrochloride 10 MG Oral TabletSYebdf5144-752d-456f-b46d-19cbba0bc3d76
898723BZP hydrochloride 5 MG Oral TabletSYebdf5144-752d-456f-b46d-19cbba0bc3d76
898687benazepril HCl 10 MG Oral TabletPSNcb93e793-fe4f-452c-e053-2995a90a73335
898690benazepril HCl 20 MG Oral TabletPSNcb93e793-fe4f-452c-e053-2995a90a73335
898719benazepril HCl 40 MG Oral TabletPSNcb93e793-fe4f-452c-e053-2995a90a73335
898723benazepril HCl 5 MG Oral TabletPSNcb93e793-fe4f-452c-e053-2995a90a73335
898687benazepril hydrochloride 10 MG Oral TabletSCDcb93e793-fe4f-452c-e053-2995a90a73335
898690benazepril hydrochloride 20 MG Oral TabletSCDcb93e793-fe4f-452c-e053-2995a90a73335
898719benazepril hydrochloride 40 MG Oral TabletSCDcb93e793-fe4f-452c-e053-2995a90a73335
898723benazepril hydrochloride 5 MG Oral TabletSCDcb93e793-fe4f-452c-e053-2995a90a73335
898723benazepril HCl 5 MG Oral TabletSYcb93e793-fe4f-452c-e053-2995a90a73335
898687BZP hydrochloride 10 MG Oral TabletSYcb93e793-fe4f-452c-e053-2995a90a73335
898690BZP hydrochloride 20 MG Oral TabletSYcb93e793-fe4f-452c-e053-2995a90a73335
898719BZP hydrochloride 40 MG Oral TabletSYcb93e793-fe4f-452c-e053-2995a90a73335
898723BZP hydrochloride 5 MG Oral TabletSYcb93e793-fe4f-452c-e053-2995a90a73335
898723benazepril HCl 5 MG Oral TabletPSN53fea330-cc4a-3b7e-e054-00144ff88e884
898723benazepril hydrochloride 5 MG Oral TabletSCD53fea330-cc4a-3b7e-e054-00144ff88e884
898723benazepril HCl 5 MG Oral TabletSY53fea330-cc4a-3b7e-e054-00144ff88e884
898723BZP hydrochloride 5 MG Oral TabletSY53fea330-cc4a-3b7e-e054-00144ff88e884
898723benazepril HCl 5 MG Oral TabletPSN9987a842-07a5-635e-e053-2995a90afa323
898723benazepril hydrochloride 5 MG Oral TabletSCD9987a842-07a5-635e-e053-2995a90afa323
898723benazepril HCl 5 MG Oral TabletSY9987a842-07a5-635e-e053-2995a90afa323
898723BZP hydrochloride 5 MG Oral TabletSY9987a842-07a5-635e-e053-2995a90afa323
898723benazepril HCl 5 MG Oral TabletPSNad3b9ebb-c5cc-412c-9693-7f5387d8e3a41
898723benazepril hydrochloride 5 MG Oral TabletSCDad3b9ebb-c5cc-412c-9693-7f5387d8e3a41
898723benazepril HCl 5 MG Oral TabletSYad3b9ebb-c5cc-412c-9693-7f5387d8e3a41
898723BZP hydrochloride 5 MG Oral TabletSYad3b9ebb-c5cc-412c-9693-7f5387d8e3a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-335-034354703350330 TABLET, COATED in 1 BOTTLE (43547-335-03) 2019-06-300000-00-00NoNoCurrent
43547-335-1043547033510100 TABLET, COATED in 1 BOTTLE (43547-335-10) 2014-01-010000-00-00NoNoCurrent