FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
83209-399
11-digit product format
832090399
Labeler code
83209
Product ID
83209-399_41af330c-81e2-db2d-e063-6294a90a005c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Boswell Pharmacy Services LLC d/b/a BPS Wholesale
Application
ANDA203245
Marketing category
ANDA
Marketing start
2025-10-21
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
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 BESYLATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii864V2Q084H
Rxcui308135

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
83209-399-10Amlodipine Besylate10 in 1 BLISTER PACKTABLET101
83209-399-15Amlodipine Besylate15 in 1 BLISTER PACKTABLET151
83209-399-20Amlodipine Besylate20 in 1 BLISTER PACKTABLET201
83209-399-30Amlodipine Besylate30 in 1 BLISTER PACKTABLET301
83209-399-60Amlodipine Besylate60 in 1 BLISTER PACKTABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN41af64c4-b788-d827-e063-6394a90a91571
308135amlodipine 10 MG Oral TabletSCD41af64c4-b788-d827-e063-6394a90a91571
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY41af64c4-b788-d827-e063-6394a90a91571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83209-399-108320903991010 TABLET in 1 BLISTER PACK (83209-399-10) 10 tablet2025-10-21NoNoHistorical
83209-399-158320903991515 TABLET in 1 BLISTER PACK (83209-399-15) 15 tablet2025-10-21NoNoHistorical
83209-399-208320903992020 TABLET in 1 BLISTER PACK (83209-399-20) 20 tablet2025-10-21NoNoHistorical
83209-399-308320903993030 TABLET in 1 BLISTER PACK (83209-399-30) 30 tablet2025-10-21NoNoHistorical
83209-399-608320903996060 TABLET in 1 BLISTER PACK (83209-399-60) 60 tablet2025-10-21NoNoHistorical