Amlodipine and Benazepril Hydrochloride

Product NDC
0591-3761
11-digit product format
005913761
Labeler code
0591
Product ID
0591-3761_d8c10de7-f915-4dc1-a167-6729f0015ee8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine and Benazepril Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090364
Marketing category
ANDA
Marketing start
2011-07-05
Marketing end
2019-08-31
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
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3761-01EA - Each0591-3761a0241484-e5a4-4969-9d19-b0b1cd8d4ec612012-07-24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
898359amLODIPine besylate 5 MG / benazepril HCl 40 MG Oral CapsulePSN37f78ade-1f5a-4ace-9908-3d1404d286061
898359amlodipine 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSCD37f78ade-1f5a-4ace-9908-3d1404d286061
898359amlodipine (as amlodipine besylate) 5 MG / benazepril hydrochloride 40 MG Oral CapsuleSY37f78ade-1f5a-4ace-9908-3d1404d286061
898359Amlodipine 5 MG / BZP hydrochloride 40 MG Oral CapsuleSY37f78ade-1f5a-4ace-9908-3d1404d286061