FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
82804-969
11-digit product format
828040969
Labeler code
82804
Product ID
82804-969_6313edc5-d2d5-44a1-a06f-7f7829c870d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Brand name suffix
2.5 mg
Listing expiration
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
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
82804-969-00AMLODIPINE BESYLATE2.5 mg100 in 1 BOTTLETABLET1001
82804-969-11AMLODIPINE BESYLATE2.5 mg1000 in 1 BOTTLETABLET10001
82804-969-30AMLODIPINE BESYLATE2.5 mg30 in 1 BOTTLETABLET301
82804-969-55AMLODIPINE BESYLATE2.5 mg500 in 1 BOTTLETABLET5001
82804-969-60AMLODIPINE BESYLATE2.5 mg60 in 1 BOTTLETABLET601
82804-969-72AMLODIPINE BESYLATE2.5 mg120 in 1 BOTTLETABLET1201
82804-969-90AMLODIPINE BESYLATE2.5 mg90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-969-00EA - Each82804-969e341a6d7-ff24-4712-ac59-74bdeed6e4ab12025-03-04
82804-969-11EA - Each82804-969c9b8fe9e-6cda-423c-9fcd-497cae5253e912025-03-04
82804-969-30EA - Each82804-9695c33efc9-72c8-41d1-aa72-896aa7b703b312025-03-04
82804-969-55EA - Each82804-96972a08f5a-3d39-4e7e-949e-3bec47d12f4812025-03-04
82804-969-60EA - Each82804-9690f393f76-66d6-4102-840f-e1f6fc46917812025-03-04
82804-969-72EA - Each82804-969af2f36a4-d240-43d5-b069-7164c48abc3712025-03-04
82804-969-90EA - Each82804-969d8a4601e-1232-4214-bc7b-c7ff8c6fc4f412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-969AMLODIPINE BESYLATE 2.5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 5 MG (AMLODIPINE BESYLATE) TABLET AMLODIPINE BESYLATE 10 MG (AMLODIPINE BESYLATE) TABLET [PROFICIENT RX LP]1Current NDC, 7 package rows20250216_6313edc5-d2d5-44a1-a06f-7f7829c870d2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
82804-969-0082804096900100 TABLET in 1 BOTTLE (82804-969-00) 100 tablet2025-02-13NoNoCurrent
82804-969-11828040969111000 TABLET in 1 BOTTLE (82804-969-11) 1000 tablet2025-02-13NoNoCurrent
82804-969-308280409693030 TABLET in 1 BOTTLE (82804-969-30) 30 tablet2025-02-13NoNoCurrent
82804-969-5582804096955500 TABLET in 1 BOTTLE (82804-969-55) 500 tablet2025-02-13NoNoCurrent
82804-969-608280409696060 TABLET in 1 BOTTLE (82804-969-60) 60 tablet2025-02-13NoNoCurrent
82804-969-7282804096972120 TABLET in 1 BOTTLE (82804-969-72) 120 tablet2025-02-13NoNoCurrent
82804-969-908280409699090 TABLET in 1 BOTTLE (82804-969-90) 90 tablet2025-02-13NoNoCurrent