FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
0904-6369
11-digit product format
009046369
Labeler code
0904
Product ID
0904-6369_56f23c85-5abd-443b-afcc-fafd8a8c8dab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078226
Marketing category
ANDA
Marketing start
2013-01-20
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
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
0904-6369-61Amlodipine Besylate100 in 1 CARTONTABLET1006
0904-6369-61Amlodipine Besylate1 in 1 BLISTER PACKTABLET16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6369AMLODIPINE BESYLATE TABLET [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20241102_edf9b22c-e37e-4b4e-8a64-20bb036c7d2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNa74239bf-4684-424c-ba4e-6087e363265b18
308136amLODIPine besylate 2.5 MG Oral TabletPSNa74239bf-4684-424c-ba4e-6087e363265b18
197361amLODIPine besylate 5 MG Oral TabletPSNa74239bf-4684-424c-ba4e-6087e363265b18
308135amlodipine 10 MG Oral TabletSCDa74239bf-4684-424c-ba4e-6087e363265b18
308136amlodipine 2.5 MG Oral TabletSCDa74239bf-4684-424c-ba4e-6087e363265b18
197361amlodipine 5 MG Oral TabletSCDa74239bf-4684-424c-ba4e-6087e363265b18
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYa74239bf-4684-424c-ba4e-6087e363265b18
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYa74239bf-4684-424c-ba4e-6087e363265b18
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYa74239bf-4684-424c-ba4e-6087e363265b18
308135amLODIPine besylate 10 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amLODIPine besylate 2.5 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amLODIPine besylate 5 MG Oral TabletPSNedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308135amlodipine 10 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amlodipine 2.5 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amlodipine 5 MG Oral TabletSCDedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSYedf9b22c-e37e-4b4e-8a64-20bb036c7d2d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6369-6100904636961100 BLISTER PACK in 1 CARTON (0904-6369-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2013-01-200000-00-00NoNoCurrent