FDA.reportPublic FDA data

Amlodipine and Benazepril Hydrochloride

Product NDC
42291-015
11-digit product format
422910015
Labeler code
42291
Product ID
42291-015_51b5576e-8462-a4a5-e063-6394a90ac0bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA202239
Marketing category
ANDA
Marketing start
2023-06-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine and Benazepril Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H, N1SN99T69T
Rxcui898342, 898346, 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
42291-015-01Amlodipine and Benazepril Hydrochloride100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-015-01EA - Each42291-015a9900128-23d2-4589-a114-6a35b857060d12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-015AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AVKARE]1Current NDC, 1 package rows20230621_fe91d607-5e1f-48e4-e053-6294a90ac522.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNfe91d607-5e1f-48e4-e053-6294a90ac5223
898346amLODIPine besylate 10 MG / benazepril HCl 40 MG Oral CapsulePSNfe91d607-5e1f-48e4-e053-6294a90ac5223
898353amLODIPine besylate 5 MG / benazepril HCl 10 MG Oral CapsulePSNfe91d607-5e1f-48e4-e053-6294a90ac5223
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSNfe91d607-5e1f-48e4-e053-6294a90ac5223
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSNfe91d607-5e1f-48e4-e053-6294a90ac5223
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDfe91d607-5e1f-48e4-e053-6294a90ac5223
898346amlodipine 10 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDfe91d607-5e1f-48e4-e053-6294a90ac5223
898353amlodipine 5 MG / benazepril hydrochloride 10 MG Oral CapsuleSCDfe91d607-5e1f-48e4-e053-6294a90ac5223
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDfe91d607-5e1f-48e4-e053-6294a90ac5223
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCDfe91d607-5e1f-48e4-e053-6294a90ac5223
898346amlodipine (as amlodipine besylate) 10 MG / benazepril HCl 40 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898353amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 10 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898346Amlodipine 10 MG / BZP hydrochloride 40 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898353Amlodipine 5 MG / BZP hydrochloride 10 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSYfe91d607-5e1f-48e4-e053-6294a90ac5223

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-015-0142291001501100 CAPSULE in 1 BOTTLE (42291-015-01) 100 capsule2023-06-20NoNoCurrent