FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
42806-056
11-digit product format
428060056
Labeler code
42806
Product ID
42806-056_ea20d1c2-78a5-4674-b2c2-f74e9fdcdf28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA078552
Marketing category
ANDA
Marketing start
2011-04-25
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-056-05AMLODIPINE BESYLATE500 in 1 BOTTLETABLET50017
42806-056-09AMLODIPINE BESYLATE90 in 1 BOTTLETABLET9017
42806-056-10AMLODIPINE BESYLATE1000 in 1 BOTTLETABLET100017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-056-05EA - Each42806-05685a5b076-6d16-47e2-9e16-1c2307e1e12612012-07-24
42806-056-09EA - Each42806-05674b3d151-ebc0-4949-9869-b646342ac9dd12012-07-24
42806-056-10EA - Each42806-0562ff5bae9-0de9-4a6b-8208-9605ef1e12e012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-056AMLODIPINE BESYLATE TABLET [EPIC PHARMA, LLC]16Current NDC, Legacy NDC, 3 package rows20231228_090f3e51-8129-4b5d-97f9-ab410e14df2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN090f3e51-8129-4b5d-97f9-ab410e14df2d17
308136amLODIPine besylate 2.5 MG Oral TabletPSN090f3e51-8129-4b5d-97f9-ab410e14df2d17
197361amLODIPine besylate 5 MG Oral TabletPSN090f3e51-8129-4b5d-97f9-ab410e14df2d17
308135amlodipine 10 MG Oral TabletSCD090f3e51-8129-4b5d-97f9-ab410e14df2d17
308136amlodipine 2.5 MG Oral TabletSCD090f3e51-8129-4b5d-97f9-ab410e14df2d17
197361amlodipine 5 MG Oral TabletSCD090f3e51-8129-4b5d-97f9-ab410e14df2d17
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY090f3e51-8129-4b5d-97f9-ab410e14df2d17
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY090f3e51-8129-4b5d-97f9-ab410e14df2d17
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY090f3e51-8129-4b5d-97f9-ab410e14df2d17
197361amLODIPine besylate 5 MG Oral TabletPSN186b6149-9610-4380-9bf2-9416460692762
197361amlodipine 5 MG Oral TabletSCD186b6149-9610-4380-9bf2-9416460692762
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY186b6149-9610-4380-9bf2-9416460692762
197361amLODIPine besylate 5 MG Oral TabletPSNc411a30f-51be-490d-9bc3-d5cbe1357c3c1
197361amlodipine 5 MG Oral TabletSCDc411a30f-51be-490d-9bc3-d5cbe1357c3c1
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYc411a30f-51be-490d-9bc3-d5cbe1357c3c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-056-0542806005605500 TABLET in 1 BOTTLE (42806-056-05) 500 tablet2011-04-250000-00-00NoNoCurrent
42806-056-094280600560990 TABLET in 1 BOTTLE (42806-056-09) 90 tablet2011-04-250000-00-00NoNoCurrent
42806-056-10428060056101000 TABLET in 1 BOTTLE (42806-056-10) 1000 tablet2011-04-250000-00-00NoNoCurrent