FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
82804-970
11-digit product format
828040970
Labeler code
82804
Product ID
82804-970_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
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
5 mg
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
82804-970-00AMLODIPINE BESYLATE5 mg100 in 1 BOTTLETABLET1001
82804-970-11AMLODIPINE BESYLATE5 mg1000 in 1 BOTTLETABLET10001
82804-970-30AMLODIPINE BESYLATE5 mg30 in 1 BOTTLETABLET301
82804-970-55AMLODIPINE BESYLATE5 mg500 in 1 BOTTLETABLET5001
82804-970-60AMLODIPINE BESYLATE5 mg60 in 1 BOTTLETABLET601
82804-970-72AMLODIPINE BESYLATE5 mg120 in 1 BOTTLETABLET1201
82804-970-90AMLODIPINE BESYLATE5 mg90 in 1 AMPULETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82804-970-00EA - Each82804-97019774206-b438-40f2-85e3-0dea048e2da312025-03-04
82804-970-11EA - Each82804-97073b9ca21-515c-4870-aa18-03814fc004ad12025-03-04
82804-970-30EA - Each82804-970e3667e5e-355f-4c3c-85f5-6a462460033d12025-03-04
82804-970-55EA - Each82804-970fcd7e35b-867b-4f93-82f1-6e44b624c98912025-03-04
82804-970-60EA - Each82804-970df0c732c-7f00-4816-a88a-c0edc42ca1f012025-03-04
82804-970-72EA - Each82804-970442b5660-2976-43de-bfa5-1cc7e0063f5d12025-03-04
82804-970-90EA - Each82804-9706650e4e2-bbf2-4662-b8b3-aa539da5974a12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-970AMLODIPINE 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
82804-970-0082804097000100 TABLET in 1 BOTTLE (82804-970-00) 100 tablet2025-02-13NoNoCurrent
82804-970-11828040970111000 TABLET in 1 BOTTLE (82804-970-11) 1000 tablet2025-02-13NoNoCurrent
82804-970-308280409703030 TABLET in 1 BOTTLE (82804-970-30) 30 tablet2025-02-13NoNoCurrent
82804-970-5582804097055500 TABLET in 1 BOTTLE (82804-970-55) 500 tablet2025-02-13NoNoCurrent
82804-970-608280409706060 TABLET in 1 BOTTLE (82804-970-60) 60 tablet2025-02-13NoNoCurrent
82804-970-7282804097072120 TABLET in 1 BOTTLE (82804-970-72) 120 tablet2025-02-13NoNoCurrent
82804-970-908280409709090 TABLET in 1 AMPULE (82804-970-90) 90 tablet2025-02-13NoNoCurrent