FDA.reportPublic FDA data

Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
68180-459
11-digit product format
681800459
Labeler code
68180
Product ID
68180-459_53566d4f-ff40-4815-b922-3416cde56fb1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA078466
Marketing category
ANDA
Marketing start
2018-08-01
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5; 20 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 BESYLATE5 mg/1
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiN1SN99T69T, 864V2Q084H
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
68180-459-01Amlodipine Besylate and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE10024
68180-459-02Amlodipine Besylate and Benazepril Hydrochloride500 in 1 BOTTLECAPSULE50024
68180-459-03Amlodipine Besylate and Benazepril Hydrochloride1000 in 1 BOTTLECAPSULE100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-459-01EA - Each68180-4597faae369-edbd-4d9c-91b3-80cf7876587112019-01-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-459AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS, INC.]23Current NDC, Legacy NDC, 3 package rows20250418_968c611b-43a7-40f0-9ed3-aa67ee88364b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNf16e04b5-57b9-49cc-811b-07d85ccb5d9f102
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDf16e04b5-57b9-49cc-811b-07d85ccb5d9f102
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYf16e04b5-57b9-49cc-811b-07d85ccb5d9f102
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYf16e04b5-57b9-49cc-811b-07d85ccb5d9f102
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN968c611b-43a7-40f0-9ed3-aa67ee88364b24
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSN968c611b-43a7-40f0-9ed3-aa67ee88364b24
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSN968c611b-43a7-40f0-9ed3-aa67ee88364b24
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSN968c611b-43a7-40f0-9ed3-aa67ee88364b24
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN968c611b-43a7-40f0-9ed3-aa67ee88364b24
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN968c611b-43a7-40f0-9ed3-aa67ee88364b24
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD968c611b-43a7-40f0-9ed3-aa67ee88364b24
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD968c611b-43a7-40f0-9ed3-aa67ee88364b24
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD968c611b-43a7-40f0-9ed3-aa67ee88364b24
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD968c611b-43a7-40f0-9ed3-aa67ee88364b24
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD968c611b-43a7-40f0-9ed3-aa67ee88364b24
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD968c611b-43a7-40f0-9ed3-aa67ee88364b24
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY968c611b-43a7-40f0-9ed3-aa67ee88364b24
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN3b13554a-0f63-4238-8f55-a1400c847c9f7
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD3b13554a-0f63-4238-8f55-a1400c847c9f7
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY3b13554a-0f63-4238-8f55-a1400c847c9f7
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY3b13554a-0f63-4238-8f55-a1400c847c9f7
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNdc206611-5188-40a6-b025-61db41f68a5a1
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN4e6bf47a-ee8a-4083-8cce-a6a25260d3fb1
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDdc206611-5188-40a6-b025-61db41f68a5a1
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD4e6bf47a-ee8a-4083-8cce-a6a25260d3fb1
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY4e6bf47a-ee8a-4083-8cce-a6a25260d3fb1
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYdc206611-5188-40a6-b025-61db41f68a5a1
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYdc206611-5188-40a6-b025-61db41f68a5a1
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY4e6bf47a-ee8a-4083-8cce-a6a25260d3fb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-459-0168180045901100 CAPSULE in 1 BOTTLE (68180-459-01) 100 capsule2018-08-010000-00-00NoNoCurrent
68180-459-0268180045902500 CAPSULE in 1 BOTTLE (68180-459-02) 500 capsule2018-08-010000-00-00NoNoCurrent
68180-459-03681800459031000 CAPSULE in 1 BOTTLE (68180-459-03) 1000 capsule2018-08-010000-00-00NoNoCurrent