FDA.reportPublic FDA data

Amlodipine besylate

Product NDC
76282-238
11-digit product format
762820238
Labeler code
76282
Product ID
76282-238_44d49d27-9fc5-42f5-9366-be150a8d47ea
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA077955
Marketing category
ANDA
Marketing start
2007-11-02
Substance
AMLODIPINE BESYLATE
Active strength
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 BESYLATE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui197361, 308135, 308136

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
76282-238-052023-03-23C16284748780-1f386c649-dec0-0266-e053-dadaa90a7c1aThese 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
76282-238-102023-03-23C16284748780-1f386c649-dec0-0266-e053-dadaa90a7c1aThese 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
76282-238-902023-03-23C16284748780-1f386c649-dec0-0266-e053-dadaa90a7c1aThese 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
76282-238-052023-01-30C16284748780-1f386c649-dec0-0266-e053-dadaa90a7c1aThese 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
76282-238-102023-01-30C16284748780-1f386c649-dec0-0266-e053-dadaa90a7c1aThese 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
76282-238-902023-01-30C16284748780-1f386c649-dec0-0266-e053-dadaa90a7c1aThese 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
76282-238-05Amlodipine besylate500 in 1 BOTTLETABLET5006
76282-238-10Amlodipine besylate1000 in 1 BOTTLETABLET10006
76282-238-90Amlodipine besylate90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-238-05EA - Each76282-2380fc4321f-3768-49d6-a573-a60ba176f62812012-07-24
76282-238-10EA - Each76282-238ecf3bfd6-88fe-472f-99be-c325105cc86212012-07-24
76282-238-90EA - Each76282-238cdbd023a-a50b-49a4-b407-e7db03d5295712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-238AMLODIPINE BESYLATE TABLET [EXELAN PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20230324_efd9eda5-f497-45a3-ae13-dee729add999.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197361amLODIPine besylate 5 MG Oral TabletPSNe8958997-f098-44ce-8c21-b7064d1a962e7
197361amlodipine 5 MG Oral TabletSCDe8958997-f098-44ce-8c21-b7064d1a962e7
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYe8958997-f098-44ce-8c21-b7064d1a962e7
308135amLODIPine besylate 10 MG Oral TabletPSNefd9eda5-f497-45a3-ae13-dee729add9996
308136amLODIPine besylate 2.5 MG Oral TabletPSNefd9eda5-f497-45a3-ae13-dee729add9996
197361amLODIPine besylate 5 MG Oral TabletPSNefd9eda5-f497-45a3-ae13-dee729add9996
308135amlodipine 10 MG Oral TabletSCDefd9eda5-f497-45a3-ae13-dee729add9996
308136amlodipine 2.5 MG Oral TabletSCDefd9eda5-f497-45a3-ae13-dee729add9996
197361amlodipine 5 MG Oral TabletSCDefd9eda5-f497-45a3-ae13-dee729add9996
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYefd9eda5-f497-45a3-ae13-dee729add9996
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYefd9eda5-f497-45a3-ae13-dee729add9996
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYefd9eda5-f497-45a3-ae13-dee729add9996
197361amLODIPine besylate 5 MG Oral TabletPSNa1d358b5-c206-463a-a364-18551da8c4e65
197361amlodipine 5 MG Oral TabletSCDa1d358b5-c206-463a-a364-18551da8c4e65
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa1d358b5-c206-463a-a364-18551da8c4e65
197361amLODIPine besylate 5 MG Oral TabletPSN5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee13
197361amlodipine 5 MG Oral TabletSCD5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee13
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-238-0576282023805500 TABLET in 1 BOTTLE (76282-238-05) 500 tablet2007-11-020000-00-00NoNoCurrent
76282-238-10762820238101000 TABLET in 1 BOTTLE (76282-238-10) 1000 tablet2007-11-020000-00-00NoNoCurrent
76282-238-907628202389090 TABLET in 1 BOTTLE (76282-238-90) 90 tablet2007-11-020000-00-00NoNoCurrent