FDA.reportPublic FDA data

Benazepril Hydrochloride

Product NDC
43547-338
11-digit product format
435470338
Labeler code
43547
Product ID
43547-338_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
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
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 HYDROCHLORIDE40 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
43547-338-03Benazepril Hydrochloride30 in 1 BOTTLETABLET, COATED3011
43547-338-10Benazepril Hydrochloride100 in 1 BOTTLETABLET, COATED10011
43547-338-50Benazepril Hydrochloride500 in 1 BOTTLETABLET, COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-338-03EA - Each43547-338715fb72b-0fca-4e72-b893-69107bbcaf7012020-03-10

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-338BENAZEPRIL 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
898719benazepril HCl 40 MG Oral TabletPSN08bc0034-3b33-47d8-aec2-b36535ac85a2103
898719benazepril hydrochloride 40 MG Oral TabletSCD08bc0034-3b33-47d8-aec2-b36535ac85a2103
898719BZP hydrochloride 40 MG Oral TabletSY08bc0034-3b33-47d8-aec2-b36535ac85a2103
898719benazepril HCl 40 MG Oral TabletPSN8f46e2c9-9b3b-48d0-a307-9069e387995919
898719benazepril hydrochloride 40 MG Oral TabletSCD8f46e2c9-9b3b-48d0-a307-9069e387995919
898719BZP hydrochloride 40 MG Oral TabletSY8f46e2c9-9b3b-48d0-a307-9069e387995919
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
898719benazepril HCl 40 MG Oral TabletPSNafd616b9-0c75-48be-862d-5ac18364fd9d11
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 TabletSCDafd616b9-0c75-48be-862d-5ac18364fd9d11
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
898719BZP hydrochloride 40 MG Oral TabletSYafd616b9-0c75-48be-862d-5ac18364fd9d11
898723BZP hydrochloride 5 MG Oral TabletSYbb91223e-ffa5-4a3a-b191-fe121250c20c11
898719benazepril HCl 40 MG Oral TabletPSN4d5a8b50-dd2f-4329-9e28-93608e8fe8da8
898719benazepril hydrochloride 40 MG Oral TabletSCD4d5a8b50-dd2f-4329-9e28-93608e8fe8da8
898719BZP hydrochloride 40 MG Oral TabletSY4d5a8b50-dd2f-4329-9e28-93608e8fe8da8
898719benazepril HCl 40 MG Oral TabletPSN55c99902-3d4d-05e9-e054-00144ff8d46c7
898719benazepril hydrochloride 40 MG Oral TabletSCD55c99902-3d4d-05e9-e054-00144ff8d46c7
898719BZP hydrochloride 40 MG Oral TabletSY55c99902-3d4d-05e9-e054-00144ff8d46c7
898719benazepril HCl 40 MG Oral TabletPSN4b822870-e366-62d1-e054-00144ff88e886
898719benazepril hydrochloride 40 MG Oral TabletSCD4b822870-e366-62d1-e054-00144ff88e886
898719BZP hydrochloride 40 MG Oral TabletSY4b822870-e366-62d1-e054-00144ff88e886
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
898719benazepril HCl 40 MG Oral TabletPSN313225d7-f947-40b3-96d7-289aad300a4a5
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
898719benazepril hydrochloride 40 MG Oral TabletSCD313225d7-f947-40b3-96d7-289aad300a4a5
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
898719BZP hydrochloride 40 MG Oral TabletSY313225d7-f947-40b3-96d7-289aad300a4a5
898723BZP hydrochloride 5 MG Oral TabletSYcb93e793-fe4f-452c-e053-2995a90a73335
898690benazepril HCl 20 MG Oral TabletPSN7f819b77-2600-0a5f-e053-2a91aa0a9d152
898719benazepril HCl 40 MG Oral TabletPSN7f819b77-2600-0a5f-e053-2a91aa0a9d152
898719benazepril HCl 40 MG Oral TabletPSN471cd30a-401a-c8f9-e063-6294a90a47872
898690benazepril hydrochloride 20 MG Oral TabletSCD7f819b77-2600-0a5f-e053-2a91aa0a9d152
898719benazepril hydrochloride 40 MG Oral TabletSCD471cd30a-401a-c8f9-e063-6294a90a47872
898719benazepril hydrochloride 40 MG Oral TabletSCD7f819b77-2600-0a5f-e053-2a91aa0a9d152
898690BZP hydrochloride 20 MG Oral TabletSY7f819b77-2600-0a5f-e053-2a91aa0a9d152
898719BZP hydrochloride 40 MG Oral TabletSY471cd30a-401a-c8f9-e063-6294a90a47872
898719BZP hydrochloride 40 MG Oral TabletSY7f819b77-2600-0a5f-e053-2a91aa0a9d152
898719benazepril HCl 40 MG Oral TabletPSN722df1e3-b160-4920-9469-a6070bb5e5381
898719benazepril HCl 40 MG Oral TabletPSNe5747e8f-b1b9-4caf-9f43-36dd8401adc61
898719benazepril hydrochloride 40 MG Oral TabletSCD722df1e3-b160-4920-9469-a6070bb5e5381
898719benazepril hydrochloride 40 MG Oral TabletSCDe5747e8f-b1b9-4caf-9f43-36dd8401adc61
898719BZP hydrochloride 40 MG Oral TabletSY722df1e3-b160-4920-9469-a6070bb5e5381
898719BZP hydrochloride 40 MG Oral TabletSYe5747e8f-b1b9-4caf-9f43-36dd8401adc61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43547-338-034354703380330 TABLET, COATED in 1 BOTTLE (43547-338-03) 2019-06-300000-00-00NoNoCurrent
43547-338-1043547033810100 TABLET, COATED in 1 BOTTLE (43547-338-10) 2014-01-010000-00-00NoNoCurrent
43547-338-5043547033850500 TABLET, COATED in 1 BOTTLE (43547-338-50) 2014-01-010000-00-00NoNoCurrent