FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
69584-021
11-digit product format
695840021
Labeler code
69584
Product ID
69584-021_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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
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
69584-021-09AMLODIPINE BESYLATE2.5 mg90 in 1 BOTTLETABLET904
69584-021-50AMLODIPINE BESYLATE2.5 mg500 in 1 BOTTLETABLET5004
69584-021-90AMLODIPINE BESYLATE2.5 mg1000 in 1 BOTTLETABLET10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69584-021-09EA - Each69584-021bc2d9241-6d7c-4790-86e7-09c5bebf33f712022-08-04
69584-021-50EA - Each69584-021ac7a0d75-82b2-44ef-97ef-4c44f52732ba12022-10-06
69584-021-90EA - Each69584-0211939d614-91d9-4471-91a7-e7057e0fb96212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69584-021AMLODIPINE 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, 3 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 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 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
69584-021-096958400210990 TABLET in 1 BOTTLE (69584-021-09) 90 tablet2021-10-010000-00-00NoNoCurrent
69584-021-5069584002150500 TABLET in 1 BOTTLE (69584-021-50) 500 tablet2021-10-010000-00-00NoNoCurrent
69584-021-90695840021901000 TABLET in 1 BOTTLE (69584-021-90) 1000 tablet2021-10-010000-00-00NoNoCurrent