FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
10135-525
11-digit product format
101350525
Labeler code
10135
Product ID
10135-525_6fc90578-2c9f-43a7-9c05-a6bc8adc859f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA078552
Marketing category
ANDA
Marketing start
2017-09-15
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
5 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
10135-525-052020-01-31C16284748780-19d75b9d0-8cdd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate table ts. AMLODIPINE besylate tablets for o ral us. Initial U.S. Approval: 198 7
10135-525-102020-01-31C16284748780-19d75b9d0-8cdd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate table ts. AMLODIPINE besylate tablets for o ral us. Initial U.S. Approval: 198 7
10135-525-902020-01-31C16284748780-19d75b9d0-8cdd-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine besylate tablets safely and effectively. See full prescribing information for amlodipine besylate table ts. AMLODIPINE besylate tablets for o ral us. Initial U.S. Approval: 198 7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-525-05Amlodipine Besylate500 in 1 BOTTLETABLET5001
10135-525-10Amlodipine Besylate1000 in 1 BOTTLETABLET10001
10135-525-90Amlodipine Besylate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-525-05EA - Each10135-5256ea57ceb-d88d-43c6-be7e-469982b01c0b12017-10-13
10135-525-10EA - Each10135-525de999997-4eb3-4f08-a2a6-fc90507fbe2012017-10-13
10135-525-90EA - Each10135-525c5a96a6d-c477-41ba-a5bb-812b8ec7d75312017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-525AMLODIPINE BESYLATE TABLET [MARLEX PHARMACEUTICALS INC]1Legacy NDC, 3 package rows20170928_e5bc1507-3241-4b7d-be3f-cc365d436bbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNe5bc1507-3241-4b7d-be3f-cc365d436bbf1
308136amLODIPine besylate 2.5 MG Oral TabletPSNe5bc1507-3241-4b7d-be3f-cc365d436bbf1
197361amLODIPine besylate 5 MG Oral TabletPSNe5bc1507-3241-4b7d-be3f-cc365d436bbf1
308135amlodipine 10 MG Oral TabletSCDe5bc1507-3241-4b7d-be3f-cc365d436bbf1
308136amlodipine 2.5 MG Oral TabletSCDe5bc1507-3241-4b7d-be3f-cc365d436bbf1
197361amlodipine 5 MG Oral TabletSCDe5bc1507-3241-4b7d-be3f-cc365d436bbf1
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYe5bc1507-3241-4b7d-be3f-cc365d436bbf1
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYe5bc1507-3241-4b7d-be3f-cc365d436bbf1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYe5bc1507-3241-4b7d-be3f-cc365d436bbf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-525-0510135052505500 in 1 BOTTLEHistorical
10135-525-10101350525101000 in 1 BOTTLEHistorical
10135-525-901013505259090 in 1 BOTTLEHistorical