FDA.reportPublic FDA data

amlodipine besylate

Product NDC
10135-760
11-digit product format
101350760
Labeler code
10135
Product ID
10135-760_eb82ef86-51fa-dd36-e053-2a95a90aa5eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA207821
Marketing category
ANDA
Marketing start
2022-10-01
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [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
10135-760-102024-01-30C16284748780-11030e364-fd34-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1992
10135-760-902024-01-30C16284748780-11030e364-fd34-111a-e063-dadaa90a10e2These 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 use Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-760-10amlodipine besylate1000 in 1 BOTTLETABLET10001
10135-760-90amlodipine besylate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-760-10EA - Each10135-760286d00cc-31ad-45d9-b272-66d733d0271612022-11-07
10135-760-90EA - Each10135-760e3f9b1f2-c08e-4982-9523-5cea7b7bfa2c12022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-760AMLODIPINE BESYLATE TABLET [MARLEX PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20221021_eb82ef86-51f9-dd36-e053-2a95a90aa5eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
308136amLODIPine besylate 2.5 MG Oral TabletPSNeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
197361amLODIPine besylate 5 MG Oral TabletPSNeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
308135amlodipine 10 MG Oral TabletSCDeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
308136amlodipine 2.5 MG Oral TabletSCDeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
197361amlodipine 5 MG Oral TabletSCDeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYeb82ef86-51f9-dd36-e053-2a95a90aa5eb1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYeb82ef86-51f9-dd36-e053-2a95a90aa5eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-760-10101350760101000 TABLET in 1 BOTTLE (10135-760-10) 1000 tablet2022-10-010000-00-00NoNoCurrent
10135-760-901013507609090 TABLET in 1 BOTTLE (10135-760-90) 90 tablet2022-10-010000-00-00NoNoCurrent