FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
67877-197
11-digit product format
678770197
Labeler code
67877
Product ID
67877-197_9fb4b641-2b16-4bcb-89de-d8d5893916ec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA078925
Marketing category
ANDA
Marketing start
2010-10-20
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
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
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
1f1c6e4b-bbad-4649-afd1-7a1d671db4b1Product name120150316
63ab5fbf-2a6b-c41d-051a-39e845d718b1Product name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
b9fbc696-7d55-c52e-4f12-7e3d99cd2db4Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-197-05Amlodipine Besylate500 in 1 BOTTLETABLET50020
67877-197-10Amlodipine Besylate1000 in 1 BOTTLETABLET100020
67877-197-38Amlodipine Besylate10 in 1 CARTONTABLET1020
67877-197-38Amlodipine Besylate10 in 1 BLISTER PACKTABLET1020
67877-197-90Amlodipine Besylate90 in 1 BOTTLETABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-197-05EA - Each67877-1978c6c1dd8-ea77-404c-83c6-88a2aa506d3612012-07-24
67877-197-10EA - Each67877-19761eb2cf4-a5fe-48c2-8e27-ba9f184e29a812012-07-24
67877-197-90EA - Each67877-197fd761488-92e6-43fb-982a-0e7a1f6f179212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-197AMLODIPINE BESYLATE TABLET [ASCEND LABORATORIES, LLC]20Current NDC, Legacy NDC, 5 package rows20240622_3f4703c0-0b9e-41a0-8b70-da26683d9ed2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN921096ab-589a-4821-8d91-a6319f4a559a35
308136amLODIPine besylate 2.5 MG Oral TabletPSN921096ab-589a-4821-8d91-a6319f4a559a35
197361amLODIPine besylate 5 MG Oral TabletPSN921096ab-589a-4821-8d91-a6319f4a559a35
308135amlodipine 10 MG Oral TabletSCD921096ab-589a-4821-8d91-a6319f4a559a35
308136amlodipine 2.5 MG Oral TabletSCD921096ab-589a-4821-8d91-a6319f4a559a35
197361amlodipine 5 MG Oral TabletSCD921096ab-589a-4821-8d91-a6319f4a559a35
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY921096ab-589a-4821-8d91-a6319f4a559a35
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY921096ab-589a-4821-8d91-a6319f4a559a35
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY921096ab-589a-4821-8d91-a6319f4a559a35
308135amLODIPine besylate 10 MG Oral TabletPSN3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308136amLODIPine besylate 2.5 MG Oral TabletPSN3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amLODIPine besylate 5 MG Oral TabletPSN3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308135amlodipine 10 MG Oral TabletSCD3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308136amlodipine 2.5 MG Oral TabletSCD3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amlodipine 5 MG Oral TabletSCD3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY3f4703c0-0b9e-41a0-8b70-da26683d9ed220
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY3f4703c0-0b9e-41a0-8b70-da26683d9ed220
308135amLODIPine besylate 10 MG Oral TabletPSN47f228e9-4a34-4d14-988d-b06af90124b916
308136amLODIPine besylate 2.5 MG Oral TabletPSN47f228e9-4a34-4d14-988d-b06af90124b916
197361amLODIPine besylate 5 MG Oral TabletPSN47f228e9-4a34-4d14-988d-b06af90124b916
308135amlodipine 10 MG Oral TabletSCD47f228e9-4a34-4d14-988d-b06af90124b916
308136amlodipine 2.5 MG Oral TabletSCD47f228e9-4a34-4d14-988d-b06af90124b916
197361amlodipine 5 MG Oral TabletSCD47f228e9-4a34-4d14-988d-b06af90124b916
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY47f228e9-4a34-4d14-988d-b06af90124b916
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY47f228e9-4a34-4d14-988d-b06af90124b916
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY47f228e9-4a34-4d14-988d-b06af90124b916
308136amLODIPine besylate 2.5 MG Oral TabletPSN4ad016ec-e158-4325-9f45-4460cf78dd9814
308136amlodipine 2.5 MG Oral TabletSCD4ad016ec-e158-4325-9f45-4460cf78dd9814
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY4ad016ec-e158-4325-9f45-4460cf78dd9814
308135amLODIPine besylate 10 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amLODIPine besylate 2.5 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amLODIPine besylate 5 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amlodipine 10 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amlodipine 2.5 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine 5 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amLODIPine besylate 2.5 MG Oral TabletPSN1ff04bd2-9926-48a4-9afc-eab0789dba015
308136amLODIPine besylate 2.5 MG Oral TabletPSN1488378b-d1bb-452e-a287-09019472157a5
308136amLODIPine besylate 2.5 MG Oral TabletPSNced6d26e-8c54-4808-88b6-446344f4acd05
308136amlodipine 2.5 MG Oral TabletSCD1ff04bd2-9926-48a4-9afc-eab0789dba015
308136amlodipine 2.5 MG Oral TabletSCD1488378b-d1bb-452e-a287-09019472157a5
308136amlodipine 2.5 MG Oral TabletSCDced6d26e-8c54-4808-88b6-446344f4acd05
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYced6d26e-8c54-4808-88b6-446344f4acd05
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY1ff04bd2-9926-48a4-9afc-eab0789dba015
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY1488378b-d1bb-452e-a287-09019472157a5
898342amLODIPine besylate 10 MG / benazepril HCl 20 MG Oral CapsulePSNb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amLODIPine besylate 2.5 MG Oral TabletPSNb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amLODIPine besylate 2.5 MG Oral TabletPSN00a037f6-b17f-4d21-9a9a-0e682f68d4833
898342amlodipine 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSCDb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amlodipine 2.5 MG Oral TabletSCDb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amlodipine 2.5 MG Oral TabletSCD00a037f6-b17f-4d21-9a9a-0e682f68d4833
898342amlodipine (as amlodipine besylate) 10 MG / benazepril hydrochloride 20 MG Oral CapsuleSYb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY00a037f6-b17f-4d21-9a9a-0e682f68d4833
898342Amlodipine 10 MG / BZP hydrochloride 20 MG Oral CapsuleSYb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7193
308136amLODIPine besylate 2.5 MG Oral TabletPSN2904c6e1-2c51-8035-e063-6294a90aa04b2
308136amlodipine 2.5 MG Oral TabletSCD2904c6e1-2c51-8035-e063-6294a90aa04b2
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY2904c6e1-2c51-8035-e063-6294a90aa04b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-197-0567877019705500 TABLET in 1 BOTTLE (67877-197-05) 500 tablet2010-10-200000-00-00NoNoCurrent
67877-197-10678770197101000 TABLET in 1 BOTTLE (67877-197-10) 1000 tablet2010-10-200000-00-00NoNoCurrent
67877-197-386787701973810 BLISTER PACK in 1 CARTON (67877-197-38) / 10 TABLET in 1 BLISTER PACK10 blister pack2010-10-200000-00-00NoNoCurrent
67877-197-906787701979090 TABLET in 1 BOTTLE (67877-197-90) 90 tablet2010-10-200000-00-00NoNoCurrent