FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
69584-023
11-digit product format
695840023
Labeler code
69584
Product ID
69584-023_afdff9c9-5e2d-44e7-b5ea-a4d8836ddf05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Oxford Pharmaceuticals, LLC
Application
ANDA078414
Marketing category
ANDA
Marketing start
2021-10-01
Substance
AMLODIPINE BESYLATE
Active strength
10 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Brand name suffix
10 mg
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMLODIPINE BESYLATE10 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
69584-023-09AMLODIPINE BESYLATE10 mg90 in 1 BOTTLETABLET904
69584-023-50AMLODIPINE BESYLATE10 mg500 in 1 BOTTLETABLET5004
69584-023-90AMLODIPINE BESYLATE10 mg1000 in 1 BOTTLETABLET10004
69584-023-93AMLODIPINE BESYLATE10 mg3000 in 1 BOTTLETABLET30004
69584-023-95AMLODIPINE BESYLATE10 mg5000 in 1 BOTTLETABLET50004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-023-09EA - Each69584-0230588d923-9c6d-4bae-8e69-64c45c94d9e112022-08-04
69584-023-50EA - Each69584-0235c72611a-7707-4174-b4a5-e1012b2c290312025-05-14
69584-023-90EA - Each69584-0234f00f661-d508-4e9e-9e5d-558e9a6b2aeb12022-08-04
69584-023-93EA - Each69584-023282fee3f-ae1a-4d37-9c12-08aa9bd0922e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-023AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [OXFORD PHARMACEUTICALS, LLC]3Current NDC, Legacy NDC, 5 package rows20240130_6f20efca-943b-4bc2-a157-0931bd4d4585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN1080fcea-a5da-499d-a855-690c1355907117
308136amLODIPine besylate 2.5 MG Oral TabletPSN1080fcea-a5da-499d-a855-690c1355907117
197361amLODIPine besylate 5 MG Oral TabletPSN1080fcea-a5da-499d-a855-690c1355907117
308135amlodipine 10 MG Oral TabletSCD1080fcea-a5da-499d-a855-690c1355907117
308136amlodipine 2.5 MG Oral TabletSCD1080fcea-a5da-499d-a855-690c1355907117
197361amlodipine 5 MG Oral TabletSCD1080fcea-a5da-499d-a855-690c1355907117
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY1080fcea-a5da-499d-a855-690c1355907117
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY1080fcea-a5da-499d-a855-690c1355907117
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY1080fcea-a5da-499d-a855-690c1355907117
308135amLODIPine besylate 10 MG Oral TabletPSNea9f44a1-96cf-496a-8c07-18d8de27e5125
308135amlodipine 10 MG Oral TabletSCDea9f44a1-96cf-496a-8c07-18d8de27e5125
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYea9f44a1-96cf-496a-8c07-18d8de27e5125
308135amLODIPine besylate 10 MG Oral TabletPSN6f20efca-943b-4bc2-a157-0931bd4d45854
308136amLODIPine besylate 2.5 MG Oral TabletPSN6f20efca-943b-4bc2-a157-0931bd4d45854
197361amLODIPine besylate 5 MG Oral TabletPSN6f20efca-943b-4bc2-a157-0931bd4d45854
308135amlodipine 10 MG Oral TabletSCD6f20efca-943b-4bc2-a157-0931bd4d45854
308136amlodipine 2.5 MG Oral TabletSCD6f20efca-943b-4bc2-a157-0931bd4d45854
197361amlodipine 5 MG Oral TabletSCD6f20efca-943b-4bc2-a157-0931bd4d45854
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6f20efca-943b-4bc2-a157-0931bd4d45854
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY6f20efca-943b-4bc2-a157-0931bd4d45854
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6f20efca-943b-4bc2-a157-0931bd4d45854
308135amLODIPine besylate 10 MG Oral TabletPSNffe96aa1-db66-33e4-e053-6394a90a7e4e3
308135amlodipine 10 MG Oral TabletSCDffe96aa1-db66-33e4-e053-6394a90a7e4e3
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYffe96aa1-db66-33e4-e053-6394a90a7e4e3
308135amLODIPine besylate 10 MG Oral TabletPSN6313edc5-d2d5-44a1-a06f-7f7829c870d21
308136amLODIPine besylate 2.5 MG Oral TabletPSN6313edc5-d2d5-44a1-a06f-7f7829c870d21
197361amLODIPine besylate 5 MG Oral TabletPSN6313edc5-d2d5-44a1-a06f-7f7829c870d21
308135amlodipine 10 MG Oral TabletSCD6313edc5-d2d5-44a1-a06f-7f7829c870d21
308136amlodipine 2.5 MG Oral TabletSCD6313edc5-d2d5-44a1-a06f-7f7829c870d21
197361amlodipine 5 MG Oral TabletSCD6313edc5-d2d5-44a1-a06f-7f7829c870d21
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6313edc5-d2d5-44a1-a06f-7f7829c870d21
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY6313edc5-d2d5-44a1-a06f-7f7829c870d21
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6313edc5-d2d5-44a1-a06f-7f7829c870d21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69584-023-096958400230990 TABLET in 1 BOTTLE (69584-023-09) 90 tablet2021-10-010000-00-00NoNoCurrent
69584-023-5069584002350500 TABLET in 1 BOTTLE (69584-023-50) 500 tablet2021-10-010000-00-00NoNoCurrent
69584-023-90695840023901000 TABLET in 1 BOTTLE (69584-023-90) 1000 tablet2021-10-010000-00-00NoNoCurrent
69584-023-93695840023933000 TABLET in 1 BOTTLE (69584-023-93) 3000 tablet2021-10-01NoNoCurrent
69584-023-95695840023955000 TABLET in 1 BOTTLE (69584-023-95) 5000 tablet2021-10-010000-00-00NoNoCurrent