FDA.reportPublic FDA data

Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
68001-131
11-digit product format
680010131
Labeler code
68001
Product ID
68001-131_facbe2e1-8ede-d7e4-e053-6394a90ae44f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078466
Marketing category
ANDA
Marketing start
2015-07-16
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10; 40 mg/1; mg/1
Pharmacologic classes
Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA], Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Decreased Blood Pressure [PE], Dihydropyridine Calcium Channel Blocker [EPC], Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine Besylate and Benazepril Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 mg/1
BENAZEPRIL HYDROCHLORIDE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, N1SN99T69T
Rxcui898342, 898346, 898350, 898353, 898356, 898359

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fa898d56-9495-d6f0-309b-68a5d8e3914aProduct name420260305
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
265792b3-b999-c010-7364-a7db20b9d4d9Product name520250515
14c2c15b-f823-4ada-a40e-a440544294dcProduct name120221207
a72887ef-d675-499f-af4b-78688f6855cdProduct name120191002
a4484670-2869-6416-f6ff-03b1b3cbd1b0Product name220190415
4a27501f-a987-48a5-99b4-e983d4744d76Product name720181211
18600d07-613d-bf9c-2711-fe40c06f3393Product name520180703
bded1554-44de-900a-5297-403365d6d4b2Product name320170110
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-131-00Amlodipine Besylate and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-131-00EA - Each68001-131c43af1dc-65f7-41f9-b7f8-274062d70e1d12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
POVIDONESINACTIVE INGREDIENTFZ989GH94EAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
SHELLACINACTIVE INGREDIENT46N107B71OAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-131AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [BLUEPOINT LABORATORIES]13Current NDC, Legacy NDC, 1 package rows20230504_df8e23c8-6c8f-4293-8a37-5ad3d48dba94.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSNdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSNdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSNdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSNdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSYdf8e23c8-6c8f-4293-8a37-5ad3d48dba9413

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-131-0068001013100100 CAPSULE in 1 BOTTLE (68001-131-00) 100 capsule2015-07-160000-00-00NoNoCurrent