FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
43547-336
11-digit product format
435470336
Labeler code
43547
Product ID
43547-336_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
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, 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
43547-336-03Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3011
43547-336-10Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED10011
43547-336-50Benazepril Hydrochloride500 in 1 BOTTLETABLET, COATED50011

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 [PREFERRED PHARMACEUTICALS, INC.]2
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [PREFERRED PHARMACEUTICALS, INC.]2
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
43547-336BENAZEPRIL HYDROCHLORIDE TABLET, COATED [SOLCO HEALTHCARE U.S., LLC]11Current NDC, Legacy NDC, 3 package rows20241224_bb91223e-ffa5-4a3a-b191-fe121250c20c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898687benazepril HCl 10 MG Oral TabletPSNb0d3122a-5332-4af6-98d8-520ed70ace62102
898687benazepril hydrochloride 10 MG Oral TabletSCDb0d3122a-5332-4af6-98d8-520ed70ace62102
898687BZP hydrochloride 10 MG Oral TabletSYb0d3122a-5332-4af6-98d8-520ed70ace62102
898687benazepril HCl 10 MG Oral TabletPSN355811f0-2885-0d49-e054-00144ff8d46c20
898687benazepril hydrochloride 10 MG Oral TabletSCD355811f0-2885-0d49-e054-00144ff8d46c20
898687BZP hydrochloride 10 MG Oral TabletSY355811f0-2885-0d49-e054-00144ff8d46c20
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
898687benazepril HCl 10 MG Oral TabletPSN032ea0f7-3304-4778-b3a6-6125ea7537ab14
898690benazepril HCl 20 MG Oral TabletPSN032ea0f7-3304-4778-b3a6-6125ea7537ab14
898687benazepril hydrochloride 10 MG Oral TabletSCD032ea0f7-3304-4778-b3a6-6125ea7537ab14
898690benazepril hydrochloride 20 MG Oral TabletSCD032ea0f7-3304-4778-b3a6-6125ea7537ab14
898687BZP hydrochloride 10 MG Oral TabletSY032ea0f7-3304-4778-b3a6-6125ea7537ab14
898690BZP hydrochloride 20 MG Oral TabletSY032ea0f7-3304-4778-b3a6-6125ea7537ab14
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
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
898687benazepril HCl 10 MG Oral TabletPSN7274fdaf-1247-2b2f-e053-2991aa0ad3f65
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
898687benazepril hydrochloride 10 MG Oral TabletSCD7274fdaf-1247-2b2f-e053-2991aa0ad3f65
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 TabletSY7274fdaf-1247-2b2f-e053-2991aa0ad3f65
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
898687benazepril HCl 10 MG Oral TabletPSN3631d1dc-45e1-0588-e054-00144ff88e884
898687benazepril HCl 10 MG Oral TabletPSNa7e4e43a-7abc-e2a5-e053-2995a90ab5f44
898687benazepril hydrochloride 10 MG Oral TabletSCDa7e4e43a-7abc-e2a5-e053-2995a90ab5f44
898687benazepril hydrochloride 10 MG Oral TabletSCD3631d1dc-45e1-0588-e054-00144ff88e884
898687BZP hydrochloride 10 MG Oral TabletSYa7e4e43a-7abc-e2a5-e053-2995a90ab5f44
898687BZP hydrochloride 10 MG Oral TabletSY3631d1dc-45e1-0588-e054-00144ff88e884
898687benazepril HCl 10 MG Oral TabletPSN99755c59-18b9-ab7b-e053-2a95a90a41553
898687benazepril HCl 10 MG Oral TabletPSN24ea205e-9993-429e-9df6-f4163d21312c3
898687benazepril hydrochloride 10 MG Oral TabletSCD99755c59-18b9-ab7b-e053-2a95a90a41553
898687benazepril hydrochloride 10 MG Oral TabletSCD24ea205e-9993-429e-9df6-f4163d21312c3
898687BZP hydrochloride 10 MG Oral TabletSY99755c59-18b9-ab7b-e053-2a95a90a41553
898687BZP hydrochloride 10 MG Oral TabletSY24ea205e-9993-429e-9df6-f4163d21312c3
898687benazepril HCl 10 MG Oral TabletPSNce4add14-717c-47f9-b9c4-bdc58d585e5e1
898687benazepril hydrochloride 10 MG Oral TabletSCDce4add14-717c-47f9-b9c4-bdc58d585e5e1
898687BZP hydrochloride 10 MG Oral TabletSYce4add14-717c-47f9-b9c4-bdc58d585e5e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-336-034354703360330 TABLET, COATED in 1 BOTTLE (43547-336-03) 2019-06-300000-00-00NoNoCurrent
43547-336-1043547033610100 TABLET, COATED in 1 BOTTLE (43547-336-10) 2014-01-010000-00-00NoNoCurrent
43547-336-5043547033650500 TABLET, COATED in 1 BOTTLE (43547-336-50) 2014-01-010000-00-00NoNoCurrent