FDA.reportPublic FDA data

Amlodipine besylate

Product NDC
71335-0833
11-digit product format
713350833
Labeler code
71335
Product ID
71335-0833_c9d18f34-5d9f-4f67-afbd-d28b28cbe15e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077955
Marketing category
ANDA
Marketing start
2007-11-02
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
Rxcui308136

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71335-0833-12024-05-15C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-22024-05-15C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-32024-05-15C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-42024-05-15C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-52024-05-15C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-62024-05-15C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-12024-01-30C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-22024-01-30C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-32024-01-30C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-42024-01-30C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-52024-01-30C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992
71335-0833-62024-01-30C16284748780-11030e365-28bb-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use AMLODIPINE BESYLATE TABLETS safely and effectively. See full prescribing information for AMLODIPINE BESYLATE TABLETS. AMLODIPINE BESYLATE tablets, for oral administration Initial U.S. Approval: 1992

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0833-1Amlodipine besylate30 in 1 BOTTLETABLET307
71335-0833-2Amlodipine besylate90 in 1 BOTTLETABLET907
71335-0833-3Amlodipine besylate120 in 1 BOTTLETABLET1207
71335-0833-4Amlodipine besylate60 in 1 BOTTLETABLET607
71335-0833-5Amlodipine besylate500 in 1 BOTTLETABLET5007
71335-0833-6Amlodipine besylate10 in 1 BOTTLETABLET107
71335-0833-7Amlodipine besylate100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0833-2EA - Each71335-0833cf4e145c-e71b-492f-b3a3-137abc2e49db12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0833AMLODIPINE BESYLATE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 7 package rows20240517_c3742b31-11f6-4c11-98e3-75916a1982d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308136amLODIPine besylate 2.5 MG Oral TabletPSNc3742b31-11f6-4c11-98e3-75916a1982d47
308136amlodipine 2.5 MG Oral TabletSCDc3742b31-11f6-4c11-98e3-75916a1982d47
308136amlodipine (as amlodipine besylate) 2.5 MG Oral TabletSYc3742b31-11f6-4c11-98e3-75916a1982d47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0833-17133508330130 TABLET in 1 BOTTLE (71335-0833-1) 30 tablet2018-10-100000-00-00NoNoCurrent
71335-0833-27133508330290 TABLET in 1 BOTTLE (71335-0833-2) 90 tablet2018-05-160000-00-00NoNoCurrent
71335-0833-371335083303120 TABLET in 1 BOTTLE (71335-0833-3) 120 tablet2021-12-270000-00-00NoNoCurrent
71335-0833-47133508330460 TABLET in 1 BOTTLE (71335-0833-4) 60 tablet2019-10-020000-00-00NoNoCurrent
71335-0833-571335083305500 TABLET in 1 BOTTLE (71335-0833-5) 500 tablet2018-05-110000-00-00NoNoCurrent
71335-0833-67133508330610 TABLET in 1 BOTTLE (71335-0833-6) 10 tablet2021-12-270000-00-00NoNoCurrent
71335-0833-771335083307100 TABLET in 1 BOTTLE (71335-0833-7) 100 tablet2024-04-04NoNoHistorical