FDA.reportPublic FDA data

Amlodipine Besylate and Benazepril Hydrochloride

Product NDC
33261-982
11-digit product format
332610982
Labeler code
33261
Product ID
33261-982_bbb38451-c948-492b-9998-cebf028a6052
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA202239
Marketing category
ANDA
Marketing start
2012-09-05
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS],Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA],Decreased Blood Pressure [PE]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-982-302020-01-31C16284748780-19d75b9d0-764b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
33261-982-602020-01-31C16284748780-19d75b9d0-764b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995
33261-982-902020-01-31C16284748780-19d75b9d0-764b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine besylate and benazepril hydrochloride safely and effectively. See full prescribing information for amlodipine besylate and benazepril hydrochloride capsules. Amlodipine Besylate and Benazepril Hydrochloride Capsules Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-982-30Amlodipine Besylate and Benazepril Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE301
33261-982-60Amlodipine Besylate and Benazepril Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE601
33261-982-90Amlodipine Besylate and Benazepril Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-982AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140321_178f8088-43ef-4e2c-a108-d86cd43df1ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898356amLODIPine besylate 5 MG / benazepril HCl 20 MG Oral CapsulePSN178f8088-43ef-4e2c-a108-d86cd43df1ae1
898356amlodipine 5 MG / benazepril hydrochloride 20 MG Oral CapsuleSCD178f8088-43ef-4e2c-a108-d86cd43df1ae1
898356amlodipine (as amlodipine besylate) 5 MG / benazepril HCl 20 MG Oral CapsuleSY178f8088-43ef-4e2c-a108-d86cd43df1ae1
898356Amlodipine 5 MG / BZP hydrochloride 20 MG Oral CapsuleSY178f8088-43ef-4e2c-a108-d86cd43df1ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-982-303326109823030 in 1 BOTTLE, PLASTICHistorical
33261-982-603326109826060 in 1 BOTTLE, PLASTICHistorical
33261-982-903326109829090 in 1 BOTTLE, PLASTICHistorical