FDA.reportPublic FDA data

AMLODIPINE BESYLATE

Product NDC
70518-0297
11-digit product format
705180297
Labeler code
70518
Product ID
70518-0297_50128613-4e6a-bb72-e063-6394a90a0042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMLODIPINE BESYLATE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA077073
Marketing category
ANDA
Marketing start
2017-03-08
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AMLODIPINE BESYLATE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-0297-02023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-02023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-02023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-12023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-12023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-12023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-22023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-22023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-22023-12-12C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-02022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-02022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-02022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-12022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-12022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-12022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-22022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-22022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-22022-01-28C16284748780-1d6a99b39-bda8-a426-e053-dadaa90af4c2These 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
70518-0297-0AMLODIPINE BESYLATE30 in 1 BLISTER PACKTABLET3014
70518-0297-1AMLODIPINE BESYLATE90 in 1 BOTTLE, PLASTICTABLET9014
70518-0297-2AMLODIPINE BESYLATE30 in 1 BOTTLE, PLASTICTABLET3014
70518-0297-3AMLODIPINE BESYLATE90 in 1 BOTTLE, PLASTICTABLET9014
70518-0297-4AMLODIPINE BESYLATE50 in 1 BOXTABLET5014
70518-0297-5AMLODIPINE BESYLATE1 in 1 POUCHTABLET114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0297AMLODIPINE BESYLATE TABLET [REMEDYREPACK INC.]10Current NDC, Legacy NDC, 6 package rows20250504_a6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSNa6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb5514
308135amlodipine 10 MG Oral TabletSCDa6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb5514
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSYa6fa364c-3ad6-4bf9-b9ee-5ec3b1a7eb5514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0297-07051802970030 TABLET in 1 BLISTER PACK (70518-0297-0) 30 tablet2017-03-080000-00-00NoNoCurrent
70518-0297-17051802970190 TABLET in 1 BOTTLE, PLASTIC (70518-0297-1) 90 tablet2017-04-240000-00-00NoNoCurrent
70518-0297-27051802970230 in 1 BOTTLE, PLASTICHistorical
70518-0297-37051802970390 in 1 BOTTLE, PLASTICHistorical
70518-0297-47051802970450 POUCH in 1 BOX (70518-0297-4) / 1 TABLET in 1 POUCH (70518-0297-5) 50 pouch2026-04-22NoNoHistorical
70518-0297-5705180297051 in 1 POUCHHistorical