FDA.reportPublic FDA data

Amlodipine Besylate

Product NDC
0615-6578
11-digit product format
006156578
Labeler code
0615
Product ID
0615-6578_789f7015-8b9c-4c80-98ea-71acdf80581c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
amlodipine besylate
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA076418
Marketing category
ANDA
Marketing start
2011-03-11
Marketing end
0000-00-00
Substance
AMLODIPINE BESYLATE
Active strength
10 mg/1
Pharmacologic classes
Calcium Channel Antagonists [MoA],Dihydropyridine Calcium Channel Blocker [EPC],Dihydropyridines [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-6578DDiscontinued by firm2026-07-31
excluded packagepackage0615-65780615-6578-05DDiscontinued by firm2026-07-31
excluded packagepackage0615-65780615-6578-31DDiscontinued by firm2026-07-31
excluded packagepackage0615-65780615-6578-39DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A076418-001AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 2.5MG BASETABLET / ORAL2005-10-03
A076418-002AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 5MG BASETABLET / ORAL2005-10-03
A076418-003AMLODIPINE BESYLATEAMLODIPINE BESYLATEEQ 10MG BASETABLET / ORAL2005-10-03

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-6578-052021-03-05C16284748780-19d75b9d0-be36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
0615-6578-312021-03-05C16284748780-19d75b9d0-be36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
0615-6578-392021-03-05C16284748780-19d75b9d0-be36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
0615-6578-052020-01-31C16284748780-19d75b9d0-be36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
0615-6578-312020-01-31C16284748780-19d75b9d0-be36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987
0615-6578-392020-01-31C16284748780-19d75b9d0-be36-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use amlodipine safely and effectively. See full prescribing information for amlodipine besylate tablets. Amlodipine Besylate Tablets, USP for oral administration Initial U.S. Approval: 1987

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE BESYLATE TABLET AMLODIPINE BESYLATE (AMLODIPINE) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8