FDA.reportPublic FDA data

NDC 57664-570 - Amlodipine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57664-570
Package NDCs from labels
57664-570-99, 57664-570-88, 57664-570-13, 57664-570-18
Manufacturer
State of Florida DOH Central Pharmacy
Effective date
2013-08-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine - State of Florida DOH Central PharmacyState of Florida DOH Central Pharmacy2013-08-09HUMAN PRESCRIPTION DRUG LABEL
Amlodipine - CARACO PHARMACEUTICAL LABORATORIES, LTD.CARACO PHARMACEUTICAL LABORATORIES, LTD.2008-12-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57664-570-13Amlodipine500 in 1 BOTTLETABLET5001
57664-570-18Amlodipine1000 in 1 BOTTLETABLET10001
57664-570-88Amlodipine100 in 1 BOTTLETABLET1001
57664-570-99Amlodipine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-570AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]14 package rows20090320_b52e2905-f906-4c46-bb24-2c7754c5d75b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57664-570-13EA - Each57664-570580e2f11-1b48-423e-8de8-93ea0d21237b12013-02-13
57664-570-18EA - Each57664-57081a29e57-5a7e-4301-9478-d80acdb8d64012013-02-13
57664-570-99EA - Each57664-570da356505-a475-4bfc-a8f2-bc392a32d44e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
AMLODIPINE BESYLATEACTIVE INGREDIENT864V2Q084HAMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
AmlodipineACTIVE MOIETY1J444QC288AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
AMLODIPINEACTIVE MOIETY1J444QC288AMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KAMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JAMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
dibasic calcium phosphateINACTIVE INGREDIENTAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
sodium starch glycolateINACTIVE INGREDIENTAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2AMLODIPINE (AMLODIPINE BESYLATE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINAlembic Pharmaceuticals Limitedecab983e-6ed8-4440-b7b4-7ac4bf39b26c2025-05-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEStrides Pharma Science Limited9b76e441-e6a5-4036-8276-b7788ade5c442025-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions921096ab-589a-4821-8d91-a6319f4a559a2025-04-09Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutionsdc2107cd-edfa-44a6-b139-edee6ccf47ce2025-04-08Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions00a037f6-b17f-4d21-9a9a-0e682f68d4832025-04-02Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILCamber Pharmaceuticals, Inc.99865c67-5475-4e60-98d5-a8fa850fe9ba2025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC313fe7ba-2fbd-bb4d-e063-6294a90a37492025-03-26Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions1dd12925-ede8-4ad5-9309-d8c79da1cebf2025-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 2.5 mgAMLODIPINE BESYLATEProficient Rx LP6313edc5-d2d5-44a1-a06f-7f7829c870d22025-02-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATERedpharm Drugfc61eee9-ee15-9078-e053-6394a90a22f42025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEDIRECT RXb8b9a3cd-c4e7-dfeb-e053-2a95a90aa7192025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENCS HealthCare of KY, LLC dba Vangard Labs47f228e9-4a34-4d14-988d-b06af90124b92025-01-16Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEPreferred Pharmaceuticals Inc.7c75fa72-9b0f-44bf-a745-dfa647ed1e782025-01-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
amlodipine,valsartan and hydrochlorothiazideAMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited1ea4f227-b97a-49f1-bbc3-1dede2c1866d2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE AND OLMESARTAN MEDOXOMILAMLODIPINE AND OLMESARTAN MEDOXOMILMicro Labs Limited7fcf6a87-7b3e-4cef-8c47-c8a008cfea822025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATE 10 mgAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC1871ddaf-ed2c-c3ce-e063-6394a90a1bee2024-12-20Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQuality Care Products, LLCa75e4797-6b7f-4366-9105-79d6877adac52024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEQuality Care Products, LLC6b7c18ef-3a85-4ae3-9135-7ac30a0dde082024-12-17Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308135
unii: 864V2Q084H
amlodipine besylateAMLODIPINE BESYLATEMylan Pharmaceuticals Inc.180ee374-24f2-4b9c-9d54-8815f2b1dc9b2024-11-28Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.