FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
71335-0945
11-digit product format
713350945
Labeler code
71335
Product ID
71335-0945_c05d5214-281b-43ea-9cab-2b1f349941bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine Besylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078925
Marketing category
ANDA
Marketing start
2010-10-20
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
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
71335-0945-0Amlodipine Besylate7 in 1 BOTTLETABLET711
71335-0945-1Amlodipine Besylate30 in 1 BOTTLETABLET3011
71335-0945-2Amlodipine Besylate90 in 1 BOTTLETABLET9011
71335-0945-3Amlodipine Besylate60 in 1 BOTTLETABLET6011
71335-0945-4Amlodipine Besylate120 in 1 BOTTLETABLET12011
71335-0945-5Amlodipine Besylate100 in 1 BOTTLETABLET10011
71335-0945-6Amlodipine Besylate800 in 1 BOTTLETABLET80011
71335-0945-7Amlodipine Besylate1000 in 1 BOTTLETABLET100011
71335-0945-8Amlodipine Besylate180 in 1 BOTTLETABLET18011
71335-0945-9Amlodipine Besylate10 in 1 BOTTLETABLET1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0945AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20240829_6cf5ece4-4d4e-478e-be8f-bd198c6edc5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amLODIPine besylate 2.5 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amLODIPine besylate 5 MG Oral TabletPSN6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amlodipine 10 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amlodipine 2.5 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine 5 MG Oral TabletSCD6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11
197361amlodipine (as amlodipine besylate) 5 MG Oral TabletSY6cf5ece4-4d4e-478e-be8f-bd198c6edc5d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0945-0713350945007 TABLET in 1 BOTTLE (71335-0945-0) 7 tablet2024-07-23NoNoHistorical
71335-0945-17133509450130 TABLET in 1 BOTTLE (71335-0945-1) 30 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-27133509450290 TABLET in 1 BOTTLE (71335-0945-2) 90 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-37133509450360 TABLET in 1 BOTTLE (71335-0945-3) 60 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-471335094504120 TABLET in 1 BOTTLE (71335-0945-4) 120 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-571335094505100 TABLET in 1 BOTTLE (71335-0945-5) 100 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-671335094506800 TABLET in 1 BOTTLE (71335-0945-6) 800 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-7713350945071000 TABLET in 1 BOTTLE (71335-0945-7) 1000 tablet2024-07-230000-00-00NoNoCurrent
71335-0945-871335094508180 TABLET in 1 BOTTLE (71335-0945-8) 180 tablet2024-07-23NoNoHistorical
71335-0945-97133509450910 TABLET in 1 BOTTLE (71335-0945-9) 10 tablet2024-07-23NoNoHistorical