FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
43547-337
11-digit product format
435470337
Labeler code
43547
Product ID
43547-337_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
20 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 HYDROCHLORIDE20 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
43547-337-03Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3011
43547-337-10Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED10011
43547-337-50Benazepril Hydrochloride500 in 1 BOTTLETABLET, COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-337-03EA - Each43547-3375793f618-d6ef-4c00-b94e-f5c08c74146412020-03-10

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 [MEDSOURCE PHARMACEUTICALS]1
BENAZEPRILATACTIVE MOIETYJRM708L703BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1
TRIACETININACTIVE INGREDIENTXHX3C3X673BENAZEPRIL HYDROCHLORIDE TABLET, COATED [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-337BENAZEPRIL 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
898690benazepril HCl 20 MG Oral TabletPSN0653322d-70c6-45f7-a9d1-41efee1d7387103
898690benazepril hydrochloride 20 MG Oral TabletSCD0653322d-70c6-45f7-a9d1-41efee1d7387103
898690BZP hydrochloride 20 MG Oral TabletSY0653322d-70c6-45f7-a9d1-41efee1d7387103
898690benazepril HCl 20 MG Oral TabletPSN1a7b373a-9b74-4b9d-93fb-081614222e3018
898690benazepril hydrochloride 20 MG Oral TabletSCD1a7b373a-9b74-4b9d-93fb-081614222e3018
898690BZP hydrochloride 20 MG Oral TabletSY1a7b373a-9b74-4b9d-93fb-081614222e3018
898690benazepril HCl 20 MG Oral TabletPSN7aac6a2f-85fb-4c7a-b424-9c253186dffe17
898690benazepril hydrochloride 20 MG Oral TabletSCD7aac6a2f-85fb-4c7a-b424-9c253186dffe17
898690BZP hydrochloride 20 MG Oral TabletSY7aac6a2f-85fb-4c7a-b424-9c253186dffe17
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 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
898690benazepril HCl 20 MG Oral TabletPSNbe41d21c-4747-47bb-b4b7-bbfabcd7a9b14
898690benazepril HCl 20 MG Oral TabletPSN700c828c-86c6-1857-e053-2a91aa0ae3144
898690benazepril HCl 20 MG Oral TabletPSN708110e5-fa45-44e0-9011-261f4490ea454
898690benazepril hydrochloride 20 MG Oral TabletSCDbe41d21c-4747-47bb-b4b7-bbfabcd7a9b14
898690benazepril hydrochloride 20 MG Oral TabletSCD700c828c-86c6-1857-e053-2a91aa0ae3144
898690benazepril hydrochloride 20 MG Oral TabletSCD708110e5-fa45-44e0-9011-261f4490ea454
898690BZP hydrochloride 20 MG Oral TabletSYbe41d21c-4747-47bb-b4b7-bbfabcd7a9b14
898690BZP hydrochloride 20 MG Oral TabletSY700c828c-86c6-1857-e053-2a91aa0ae3144
898690BZP hydrochloride 20 MG Oral TabletSY708110e5-fa45-44e0-9011-261f4490ea454
898690benazepril HCl 20 MG Oral TabletPSN8f0570da-b698-41d5-9b93-ee20149ca0153
898690benazepril HCl 20 MG Oral TabletPSN240b76c7-9f09-45df-990e-abf927a4c58a3
898690benazepril HCl 20 MG Oral TabletPSN9535ec77-2d50-4817-e053-2995a90a007e3
898690benazepril hydrochloride 20 MG Oral TabletSCD240b76c7-9f09-45df-990e-abf927a4c58a3
898690benazepril hydrochloride 20 MG Oral TabletSCD9535ec77-2d50-4817-e053-2995a90a007e3
898690benazepril hydrochloride 20 MG Oral TabletSCD8f0570da-b698-41d5-9b93-ee20149ca0153
898690BZP hydrochloride 20 MG Oral TabletSY8f0570da-b698-41d5-9b93-ee20149ca0153
898690BZP hydrochloride 20 MG Oral TabletSY240b76c7-9f09-45df-990e-abf927a4c58a3
898690BZP hydrochloride 20 MG Oral TabletSY9535ec77-2d50-4817-e053-2995a90a007e3
898690benazepril HCl 20 MG Oral TabletPSN7f819b77-2600-0a5f-e053-2a91aa0a9d152
898690benazepril HCl 20 MG Oral TabletPSN48aadb84-1468-4cee-b566-f9b1c6fd44032
898719benazepril HCl 40 MG Oral TabletPSN7f819b77-2600-0a5f-e053-2a91aa0a9d152
898690benazepril hydrochloride 20 MG Oral TabletSCD7f819b77-2600-0a5f-e053-2a91aa0a9d152
898690benazepril hydrochloride 20 MG Oral TabletSCD48aadb84-1468-4cee-b566-f9b1c6fd44032
898719benazepril hydrochloride 40 MG Oral TabletSCD7f819b77-2600-0a5f-e053-2a91aa0a9d152
898690BZP hydrochloride 20 MG Oral TabletSY48aadb84-1468-4cee-b566-f9b1c6fd44032
898690BZP hydrochloride 20 MG Oral TabletSY7f819b77-2600-0a5f-e053-2a91aa0a9d152
898719BZP hydrochloride 40 MG Oral TabletSY7f819b77-2600-0a5f-e053-2a91aa0a9d152
898690benazepril HCl 20 MG Oral TabletPSN1ff68ace-8d61-64f5-e054-00144ff88e881
898690benazepril hydrochloride 20 MG Oral TabletSCD1ff68ace-8d61-64f5-e054-00144ff88e881
898690BZP hydrochloride 20 MG Oral TabletSY1ff68ace-8d61-64f5-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-337-034354703370330 TABLET, COATED in 1 BOTTLE (43547-337-03) 2019-06-300000-00-00NoNoCurrent
43547-337-1043547033710100 TABLET, COATED in 1 BOTTLE (43547-337-10) 2014-01-010000-00-00NoNoCurrent
43547-337-5043547033750500 TABLET, COATED in 1 BOTTLE (43547-337-50) 2014-01-010000-00-00NoNoCurrent