FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
70518-2632
11-digit product format
705182632
Labeler code
70518
Product ID
70518-2632_4a7be9eb-5e59-90e8-e063-6394a90aad9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078925
Marketing category
ANDA
Marketing start
2020-03-17
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
70518-2632-02023-03-13C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-12023-03-13C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-22023-03-13C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-32023-03-13C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-02023-01-30C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-12023-01-30C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-22023-01-30C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-32023-01-30C16284748780-1f386c649-cf4f-0266-e053-dadaa90a7c1aThese 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
70518-2632-0Amlodipine Besylate30 in 1 BLISTER PACKTABLET3015
70518-2632-1Amlodipine Besylate90 in 1 BOTTLE, PLASTICTABLET9015
70518-2632-2Amlodipine Besylate7 in 1 BLISTER PACKTABLET715
70518-2632-3Amlodipine Besylate28 in 1 BLISTER PACKTABLET2815
70518-2632-4Amlodipine Besylate30 in 1 BOTTLE, PLASTICTABLET3015
70518-2632-5Amlodipine Besylate30 in 1 BLISTER PACKTABLET3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2632-0EA - Each70518-263295debb62-499b-4f85-84c0-16e9b98d4d8312023-01-09
70518-2632-1EA - Each70518-2632a8efda55-254e-4fb0-826c-b81ca881ad3412023-01-09
70518-2632-2EA - Each70518-2632013580ee-06da-4d7f-9cb3-89696d7ae20812023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2632AMLODIPINE BESYLATE TABLET [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 6 package rows20250326_58a67272-c4c7-4e2c-85a5-9d39034d12c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308135amLODIPine besylate 10 MG Oral TabletPSN58a67272-c4c7-4e2c-85a5-9d39034d12c315
308135amlodipine 10 MG Oral TabletSCD58a67272-c4c7-4e2c-85a5-9d39034d12c315
308135amlodipine (as amlodipine besylate) 10 MG Oral TabletSY58a67272-c4c7-4e2c-85a5-9d39034d12c315

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2632-07051826320030 TABLET in 1 BLISTER PACK (70518-2632-0) 30 tablet2020-03-170000-00-00NoNoCurrent
70518-2632-17051826320190 TABLET in 1 BOTTLE, PLASTIC (70518-2632-1) 90 tablet2020-04-040000-00-00NoNoCurrent
70518-2632-2705182632027 TABLET in 1 BLISTER PACK (70518-2632-2) 7 tablet2021-08-120000-00-00NoNoCurrent
70518-2632-37051826320328 TABLET in 1 BLISTER PACK (70518-2632-3) 28 tablet2021-12-220000-00-00NoNoCurrent
70518-2632-47051826320430 in 1 BOTTLE, PLASTICHistorical
70518-2632-57051826320530 TABLET in 1 BLISTER PACK (70518-2632-5) 30 tablet2025-06-09NoNoHistorical