FDA.reportPublic FDA data

Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
55111-341
11-digit product format
551110341
Labeler code
55111
Product ID
55111-341_6fafdf6a-6153-9a62-1774-755f2bcf0cc2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Dr.Reddy's Laboratories Limited
Application
ANDA077183
Marketing category
ANDA
Marketing start
2010-04-19
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
10; 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 BESYLATE10 mg/1
BENAZEPRIL HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

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

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
55111-341-01Amlodipine Besylate and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE10016
55111-341-05Amlodipine Besylate and Benazepril Hydrochloride500 in 1 BOTTLECAPSULE50016
55111-341-30Amlodipine Besylate and Benazepril Hydrochloride30 in 1 BOTTLECAPSULE3016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-341-01EA - Each55111-341f0b0ebf9-aa4c-4007-9e7e-46170991736312012-07-24
55111-341-05EA - Each55111-341c6b00603-36f2-4a63-b549-5e1973bf24df12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
crospovidoneINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
gelatinINACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]11
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRIL HYDROCHLORIDEACTIVE INGREDIENTN1SN99T69TAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
BENAZEPRILACTIVE MOIETYUDM7Q7QWP8AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
BENAZEPRILATACTIVE MOIETYJRM708L703AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
crospovidoneINACTIVE INGREDIENT68401960MKAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE BLACKINACTIVE INGREDIENTXM0M87F357AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
GELATININACTIVE INGREDIENT2G86QN327LAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPAMLOBENZ CAPSULE [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-341AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [DR.REDDY'S LABORATORIES LIMITED]16Current NDC, Legacy NDC, 3 package rows20221224_ca014f06-982c-6fe1-9948-a3701dd35d34.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNca014f06-982c-6fe1-9948-a3701dd35d3416
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDca014f06-982c-6fe1-9948-a3701dd35d3416
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYca014f06-982c-6fe1-9948-a3701dd35d3416
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN7a75935a-31af-4571-b7d9-8c297a635b574
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD7a75935a-31af-4571-b7d9-8c297a635b574
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY7a75935a-31af-4571-b7d9-8c297a635b574
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY7a75935a-31af-4571-b7d9-8c297a635b574
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN106c08c2-90eb-6bc0-e063-6294a90a5a232
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD106c08c2-90eb-6bc0-e063-6294a90a5a232
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY106c08c2-90eb-6bc0-e063-6294a90a5a232
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY106c08c2-90eb-6bc0-e063-6294a90a5a232
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSN02209439-fe92-42de-81e3-51a8288debc01
898350amLODIPine besylate 2.5 MG / benazepril HCl 10 MG Oral CapsulePSN02209439-fe92-42de-81e3-51a8288debc01
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD02209439-fe92-42de-81e3-51a8288debc01
898350amlodipine 2.5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCD02209439-fe92-42de-81e3-51a8288debc01
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSY02209439-fe92-42de-81e3-51a8288debc01
898350amlodipine (as amlodipine besylate) 2.5 MG / benazepril HCl 10 MG Oral CapsuleSY02209439-fe92-42de-81e3-51a8288debc01
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY43464a6b-a3b8-445b-b020-cf60f0b5e8a41
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSY02209439-fe92-42de-81e3-51a8288debc01
898350Amlodipine 2.5 MG / BZP hydrochloride 10 MG Oral CapsuleSY02209439-fe92-42de-81e3-51a8288debc01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-341-0155111034101100 CAPSULE in 1 BOTTLE (55111-341-01) 100 capsule2010-04-190000-00-00NoNoCurrent
55111-341-0555111034105500 CAPSULE in 1 BOTTLE (55111-341-05) 500 capsule2010-04-190000-00-00NoNoCurrent
55111-341-305511103413030 CAPSULE in 1 BOTTLE (55111-341-30) 30 capsule2010-04-190000-00-00NoNoCurrent