FDA.reportPublic FDA data

Amlodipine besylate

Product NDC
63629-1023
11-digit product format
636291023
Labeler code
63629
Product ID
63629-1023_0c230256-e475-41f3-94d9-05217d383eeb
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
Substance
AMLODIPINE BESYLATE
Active strength
2.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Amlodipine besylate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui308136

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
63629-1023-22020-02-25C16284748780-19d75b9cf-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
63629-1023-32020-02-25C16284748780-19d75b9cf-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
63629-1023-52020-02-25C16284748780-19d75b9cf-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
63629-1023-62020-02-25C16284748780-19d75b9cf-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
63629-1023-82020-02-25C16284748780-19d75b9cf-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
63629-1023-22020-01-31C16284748780-19d75b9cf-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
63629-1023-32020-01-31C16284748780-19d75b9cf-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
63629-1023-52020-01-31C16284748780-19d75b9cf-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
63629-1023-62020-01-31C16284748780-19d75b9cf-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
63629-1023-82020-01-31C16284748780-19d75b9cf-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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1023-2Amlodipine besylate30 in 1 BOTTLETABLET309
63629-1023-3Amlodipine besylate300 in 1 BOTTLETABLET3009
63629-1023-5Amlodipine besylate500 in 1 BOTTLETABLET5009
63629-1023-6Amlodipine besylate60 in 1 BOTTLETABLET609
63629-1023-8Amlodipine besylate800 in 1 BOTTLETABLET8009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1023AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 5 package rows20240110_498a9b21-34b9-4373-930b-5ed43201a345.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSN498a9b21-34b9-4373-930b-5ed43201a3459
308136amlodipine 2.5 MG Oral TabletSCD498a9b21-34b9-4373-930b-5ed43201a3459
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY498a9b21-34b9-4373-930b-5ed43201a3459

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1023-26362910230230 TABLET in 1 BOTTLE (63629-1023-2) 30 tablet2022-01-030000-00-00NoNoCurrent
63629-1023-363629102303300 TABLET in 1 BOTTLE (63629-1023-3) 300 tablet2022-01-030000-00-00NoNoCurrent
63629-1023-563629102305500 TABLET in 1 BOTTLE (63629-1023-5) 500 tablet2022-01-030000-00-00NoNoCurrent
63629-1023-66362910230660 TABLET in 1 BOTTLE (63629-1023-6) 60 tablet2022-01-030000-00-00NoNoCurrent
63629-1023-863629102308800 TABLET in 1 BOTTLE (63629-1023-8) 800 tablet2022-01-030000-00-00NoNoCurrent