FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
53002-3351
11-digit product format
530023351
Labeler code
53002
Product ID
53002-3351_286895ac-9aea-48f7-9337-d365e60f8285
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA078925
Marketing category
ANDA
Marketing start
2010-10-20
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
2023-12-31
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
53002-3351-02025-01-30C16284748780-12cef2736-a277-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE besylate tablets for oral administration Initial U.S. Approval: 1992
53002-3351-32025-01-30C16284748780-12cef2736-a277-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE besylate tablets for oral administration Initial U.S. Approval: 1992
53002-3351-62025-01-30C16284748780-12cef2736-a277-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE besylate tablets for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-3351-0Amlodipine Besylate100 in 1 BOTTLETABLET1004
53002-3351-3Amlodipine Besylate30 in 1 BOTTLETABLET304
53002-3351-6Amlodipine Besylate60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-3351AMLODIPINE BESYLATE TABLET [RPK PHARMACEUTICALS, INC.]4Legacy NDC, 3 package rows20220331_80f67011-1db6-4035-9521-05522567d6ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN80f67011-1db6-4035-9521-05522567d6ab4
308135amlodipine 10 MG Oral TabletSCD80f67011-1db6-4035-9521-05522567d6ab4
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY80f67011-1db6-4035-9521-05522567d6ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-3351-053002335100100 TABLET in 1 BOTTLE (53002-3351-0) 100 tablet2021-01-010000-00-00NoNoCurrent
53002-3351-35300233510330 TABLET in 1 BOTTLE (53002-3351-3) 30 tablet2021-01-010000-00-00NoNoCurrent
53002-3351-65300233510660 TABLET in 1 BOTTLE (53002-3351-6) 60 tablet2021-01-010000-00-00NoNoCurrent