FDA.reportPublic FDA data

Amlodipine besylate

Product NDC
63629-7641
11-digit product format
636297641
Labeler code
63629
Product ID
63629-7641_fd129a24-ca5b-46ff-a466-211f4b7ab8ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077955
Marketing category
ANDA
Marketing start
2007-11-02
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
63629-7641-12020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-22020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-32020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-42020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-52020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-62020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-72020-02-25C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-12020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-22020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-32020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-42020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-52020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-62020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
63629-7641-72020-01-31C16284748780-19d75b9cf-e0b1-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 TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7641-16362976410130 TABLET in 1 BOTTLE (63629-7641-1) 30 tablet2018-05-220000-00-00NoNoCurrent
63629-7641-26362976410260 TABLET in 1 BOTTLE (63629-7641-2) 60 tablet2018-05-220000-00-00NoNoCurrent
63629-7641-36362976410390 TABLET in 1 BOTTLE (63629-7641-3) 90 tablet2018-05-220000-00-00NoNoCurrent
63629-7641-463629764104300 TABLET in 1 BOTTLE (63629-7641-4) 300 tablet2018-05-220000-00-00NoNoCurrent
63629-7641-563629764105500 TABLET in 1 BOTTLE (63629-7641-5) 500 tablet2018-05-220000-00-00NoNoCurrent
63629-7641-663629764106800 TABLET in 1 BOTTLE (63629-7641-6) 800 tablet2018-05-220000-00-00NoNoCurrent
63629-7641-7636297641071000 TABLET in 1 BOTTLE (63629-7641-7) 1000 tablet2018-05-220000-00-00NoNoCurrent