FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
55648-422
11-digit product format
556480422
Labeler code
55648
Product ID
55648-422_bc38c309-978f-47ec-9357-aa73b81f9c39
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
WOCKHARDT LIMITED
Application
ANDA078500
Marketing category
ANDA
Marketing start
2007-09-06
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
55648-422-012020-01-31C16284748780-19d75b9d0-23cb-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: 1987
55648-422-022020-01-31C16284748780-19d75b9d0-23cb-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: 1987
55648-422-032020-01-31C16284748780-19d75b9d0-23cb-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: 1987
55648-422-042020-01-31C16284748780-19d75b9d0-23cb-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: 1987
55648-422-052020-01-31C16284748780-19d75b9d0-23cb-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: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55648-422-01AMLODIPINE BESYLATE90 in 1 BOTTLETABLET901
55648-422-02AMLODIPINE BESYLATE1000 in 1 BOTTLETABLET10001
55648-422-03AMLODIPINE BESYLATE10 in 1 CARTONTABLET101
55648-422-03AMLODIPINE BESYLATE10 in 1 BLISTER PACKTABLET101
55648-422-04AMLODIPINE BESYLATE100 in 1 BOTTLETABLET1001
55648-422-05AMLODIPINE BESYLATE300 in 1 BOTTLETABLET3001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AAMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55648-422AMLODIPINE BESYLATE TABLET [WOCKHARDT LIMITED]1Legacy NDC, 6 package rows20110118_a3294d91-4aa9-4a94-be6a-28ccf2d74326.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNa3294d91-4aa9-4a94-be6a-28ccf2d743261
308136amLODIPine besylate 2.5 MG Oral TabletPSNa3294d91-4aa9-4a94-be6a-28ccf2d743261
197361amLODIPine besylate 5 MG Oral TabletPSNa3294d91-4aa9-4a94-be6a-28ccf2d743261
308135amlodipine 10 MG Oral TabletSCDa3294d91-4aa9-4a94-be6a-28ccf2d743261
308136amlodipine 2.5 MG Oral TabletSCDa3294d91-4aa9-4a94-be6a-28ccf2d743261
197361amlodipine 5 MG Oral TabletSCDa3294d91-4aa9-4a94-be6a-28ccf2d743261
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYa3294d91-4aa9-4a94-be6a-28ccf2d743261
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYa3294d91-4aa9-4a94-be6a-28ccf2d743261
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa3294d91-4aa9-4a94-be6a-28ccf2d743261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55648-422-015564804220190 in 1 BOTTLEHistorical
55648-422-02556480422021000 in 1 BOTTLEHistorical
55648-422-035564804220310 in 1 CARTONHistorical
55648-422-0455648042204100 in 1 BOTTLEHistorical
55648-422-0555648042205300 in 1 BOTTLEHistorical