FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
67046-019
11-digit product format
670460019
Labeler code
67046
Product ID
67046-019_5977d47a-fe44-830e-e053-2a91aa0a9f3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
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
67046-019-302022-01-28C16284748780-1d6a99b39-4e81-a426-e053-dadaa90af4c2These 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 018 019 Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-019-30Amlodipine Besylate30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-019AMLODIPINE BESYLATE TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20170918_5977d47a-fe43-830e-e053-2a91aa0a9f3d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN5977d47a-fe43-830e-e053-2a91aa0a9f3d1
197361amLODIPine besylate 5 MG Oral TabletPSN5977d47a-fe43-830e-e053-2a91aa0a9f3d1
308135amlodipine 10 MG Oral TabletSCD5977d47a-fe43-830e-e053-2a91aa0a9f3d1
197361amlodipine 5 MG Oral TabletSCD5977d47a-fe43-830e-e053-2a91aa0a9f3d1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY5977d47a-fe43-830e-e053-2a91aa0a9f3d1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY5977d47a-fe43-830e-e053-2a91aa0a9f3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-019-306704600193030 TABLET in 1 BLISTER PACK (67046-019-30) 30 tablet2017-09-180000-00-00NoNoCurrent