AMLODIPINE BESYLATE

Product NDC
58118-1127
11-digit product format
581181127
Labeler code
58118
Product ID
58118-1127_ab5c5311-3392-37b7-e053-2a95a90aca69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA077073
Marketing category
ANDA
Marketing start
2017-10-11
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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58118-1127-82024-01-30C16284748780-11030e365-3b3c-111a-e063-dadaa90a10e2e229cfde-c3ca-4d37-b8f3-3478bc806755

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1127AMLODIPINE BESYLATE TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]5Legacy NDC20200727_e229cfde-c3ca-4d37-b8f3-3478bc806755.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-1127-85811811270830 TABLET in 1 BLISTER PACK (58118-1127-8) 30 tablet2017-10-110000-00-00NoNoCurrent