FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
12634-600
11-digit product format
126340600
Labeler code
12634
Product ID
12634-600_368408e8-87e1-4092-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Apotheca Inc.
Application
ANDA077955
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12634-600-002021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-012021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-092021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-402021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-422021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-452021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-502021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-522021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-542021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-572021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-582021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-592021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-602021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-612021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-632021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-662021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-672021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-692021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-712021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-742021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-782021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-792021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-802021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-812021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-822021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-842021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-852021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-902021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-912021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-922021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-932021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-942021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-952021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-962021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-972021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-982021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987
12634-600-992021-01-29C16284748780-1ba0f9c33-3654-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use amlodipine besylate tablets, USP safely and effectively. See full prescribing information for amlodipine besylate tablets, USP. Amlodipine besylate tablets, USP for oral administration Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12634-600-00Amlodipine Besylate10 in 1 BOTTLETABLET101
12634-600-01Amlodipine Besylate100 in 1 BOTTLETABLET1001
12634-600-09Amlodipine Besylate35 in 1 BOTTLETABLET351
12634-600-40Amlodipine Besylate40 in 1 BOTTLETABLET401
12634-600-42Amlodipine Besylate42 in 1 BOTTLETABLET421
12634-600-45Amlodipine Besylate45 in 1 BOTTLETABLET451
12634-600-50Amlodipine Besylate50 in 1 BOTTLETABLET501
12634-600-52Amlodipine Besylate12 in 1 BLISTER PACKTABLET121
12634-600-54Amlodipine Besylate14 in 1 BLISTER PACKTABLET141
12634-600-57Amlodipine Besylate20 in 1 BLISTER PACKTABLET201
12634-600-58Amlodipine Besylate28 in 1 BLISTER PACKTABLET281
12634-600-59Amlodipine Besylate30 in 1 BLISTER PACKTABLET301
12634-600-60Amlodipine Besylate60 in 1 BOTTLETABLET601
12634-600-61Amlodipine Besylate10 in 1 BLISTER PACKTABLET101
12634-600-63Amlodipine Besylate3 in 1 BLISTER PACKTABLET31
12634-600-66Amlodipine Besylate6 in 1 BLISTER PACKTABLET61
12634-600-67Amlodipine Besylate7 in 1 BLISTER PACKTABLET71
12634-600-69Amlodipine Besylate9 in 1 BLISTER PACKTABLET91
12634-600-71Amlodipine Besylate30 in 1 BOTTLETABLET301
12634-600-74Amlodipine Besylate24 in 1 BOTTLETABLET241
12634-600-78Amlodipine Besylate28 in 1 BOTTLETABLET281
12634-600-79Amlodipine Besylate25 in 1 BOTTLETABLET251
12634-600-80Amlodipine Besylate20 in 1 BOTTLETABLET201
12634-600-81Amlodipine Besylate21 in 1 BOTTLETABLET211
12634-600-82Amlodipine Besylate12 in 1 BOTTLETABLET121
12634-600-84Amlodipine Besylate14 in 1 BOTTLETABLET141
12634-600-85Amlodipine Besylate15 in 1 BOTTLETABLET151
12634-600-90Amlodipine Besylate90 in 1 BOTTLETABLET901
12634-600-91Amlodipine Besylate1 in 1 BLISTER PACKTABLET11
12634-600-92Amlodipine Besylate2 in 1 BOTTLETABLET21
12634-600-93Amlodipine Besylate3 in 1 BOTTLETABLET31
12634-600-94Amlodipine Besylate4 in 1 BOTTLETABLET41
12634-600-95Amlodipine Besylate5 in 1 BOTTLETABLET51
12634-600-96Amlodipine Besylate6 in 1 BOTTLETABLET61
12634-600-97Amlodipine Besylate7 in 1 BOTTLETABLET71
12634-600-98Amlodipine Besylate8 in 1 BOTTLETABLET81
12634-600-99Amlodipine Besylate9 in 1 BOTTLETABLET91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12634-600AMLODIPINE BESYLATE TABLET [APOTHECA INC.]1Legacy NDC, 37 package rows20160701_368408e8-87e0-4092-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN368408e8-87e0-4092-e054-00144ff88e881
308135amlodipine 10 MG Oral TabletSCD368408e8-87e0-4092-e054-00144ff88e881
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY368408e8-87e0-4092-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
12634-600-001263406000010 in 1 BOTTLEHistorical
12634-600-0112634060001100 in 1 BOTTLEHistorical
12634-600-091263406000935 in 1 BOTTLEHistorical
12634-600-401263406004040 in 1 BOTTLEHistorical
12634-600-421263406004242 in 1 BOTTLEHistorical
12634-600-451263406004545 in 1 BOTTLEHistorical
12634-600-501263406005050 in 1 BOTTLEHistorical
12634-600-521263406005212 in 1 BLISTER PACKHistorical
12634-600-541263406005414 in 1 BLISTER PACKHistorical
12634-600-571263406005720 in 1 BLISTER PACKHistorical
12634-600-581263406005828 in 1 BLISTER PACKHistorical
12634-600-591263406005930 in 1 BLISTER PACKHistorical
12634-600-601263406006060 in 1 BOTTLEHistorical
12634-600-611263406006110 in 1 BLISTER PACKHistorical
12634-600-63126340600633 in 1 BLISTER PACKHistorical
12634-600-66126340600666 in 1 BLISTER PACKHistorical
12634-600-67126340600677 in 1 BLISTER PACKHistorical
12634-600-69126340600699 in 1 BLISTER PACKHistorical
12634-600-711263406007130 in 1 BOTTLEHistorical
12634-600-741263406007424 in 1 BOTTLEHistorical
12634-600-781263406007828 in 1 BOTTLEHistorical
12634-600-791263406007925 in 1 BOTTLEHistorical
12634-600-801263406008020 in 1 BOTTLEHistorical
12634-600-811263406008121 in 1 BOTTLEHistorical
12634-600-821263406008212 in 1 BOTTLEHistorical
12634-600-841263406008414 in 1 BOTTLEHistorical
12634-600-851263406008515 in 1 BOTTLEHistorical
12634-600-901263406009090 in 1 BOTTLEHistorical
12634-600-91126340600911 in 1 BLISTER PACKHistorical
12634-600-92126340600922 in 1 BOTTLEHistorical
12634-600-93126340600933 in 1 BOTTLEHistorical
12634-600-94126340600944 in 1 BOTTLEHistorical
12634-600-95126340600955 in 1 BOTTLEHistorical
12634-600-96126340600966 in 1 BOTTLEHistorical
12634-600-97126340600977 in 1 BOTTLEHistorical
12634-600-98126340600988 in 1 BOTTLEHistorical
12634-600-99126340600999 in 1 BOTTLEHistorical