FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
58517-120
11-digit product format
585170120
Labeler code
58517
Product ID
58517-120_57ff62d2-0f5d-4756-9d43-147efc7d6942
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
New Horizon Rx Group, LLC
Application
ANDA078477
Marketing category
ANDA
Marketing start
2013-08-25
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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
58517-120-302020-01-31C16284748780-19d75b9d0-fa1e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AMLODIPINE BESYLATE safely and effectively. See full prescribing information for AMLODIPINE BESYLATE. AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET for ORAL use. Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58517-120-30AMLODIPINE BESYLATE30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58517-120-30EA - Each58517-1203cbec793-be65-4e8d-af35-7f469994ccc012013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58517-120AMLODIPINE BESYLATE TABLET [NEW HORIZON RX GROUP, LLC]2Legacy NDC, 1 package rows20140101_fb5e7668-0ce4-4276-8416-0c313b59bb73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNfb5e7668-0ce4-4276-8416-0c313b59bb732
308135amlodipine 10 MG Oral TabletSCDfb5e7668-0ce4-4276-8416-0c313b59bb732
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYfb5e7668-0ce4-4276-8416-0c313b59bb732

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
58517-120-305851701203030 in 1 BOTTLEHistorical