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 13 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP445d1274-7249-476b-ad90-ff93aee56f6d2022-06-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP5f3ac64c-6e33-40c1-9b8e-dc0c8dd7e8d62022-04-01Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEExelan Pharmaceuticals, Inc.1a24433f-4464-4c6d-9456-ed1ce38e8ec42022-03-12Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
AMLODIPINE AND VALSARTANAMLODIPINE AND VALSARTANMylan Pharmaceuticals Inc.aa7e7d95-520a-461c-b1b3-e588aeb6a6132021-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LPc2c51ec3-ffb0-4240-b048-a8e424775a762021-08-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCafcffa7b-03b7-499a-b50c-37b0e28c77372021-05-11Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILGlenmark Pharmaceuticals Inc., USA2edf43fb-0755-4ffb-bc38-75a4e24325882021-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylate and Atorvastatin calciumAMLODIPINE BESYLATE AND ATORVASTATIN CALCIUMDr. Reddy's Laboratories Incabee4a34-89cc-d886-192c-32582ab8f0242021-02-16Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan Medoxomil, Amlodipine and HydrochlorothiazideOLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDETeva Pharmaceuticals USA, Inc.5c128ef2-60a6-40f3-b37f-ee139fe279872021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
MEDULLOSSEINUM PLEXARNICA MONTANA, CALCAREA PHOSPHORICA, CALENDULA OFFICINALIS, HYPERICUM PERFORATUM, MEDULLOSSEINUM, PULSATILLA, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALESeroyal USA22b7eafe-ef76-0677-e054-00144ff88e882020-10-09WarningsExact identifier
unii: L11K75P92J
Amlodipine BesylateAMLODIPINE BESYLATEProficient Rx LP9f327d08-7661-4088-b554-2f9a99a113e72020-10-01Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATECipla USA Inc.0c8d6b2f-3e4a-47a2-80e2-a34dcb3375552020-09-09Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEProficient Rx LP410aa0a5-43cf-455c-b51d-7dfbc24eee322020-02-01Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
NorvascAMLODIPINE BESYLATEPFIZER LABORATORIES DIV PFIZER INCabd6a2ca-40c2-485c-bc53-db1c652505ed2019-01-15Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINEMylan Pharmaceuticals Inc.ca60a4d5-ace7-4889-94ee-e2265fd638112018-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC17e6d552-7528-4597-9498-104cb04f32e72017-10-25Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
9ee8ed6b-bedd-409f-9736-a23e75e05e48e04b0eb9-83b5-4b33-a1e7-1c1e84f0c8972013-08-09Warnings, Adverse reactionsExact identifier
spl id: 9ee8ed6b-bedd-409f-9736-a23e75e05e48
spl set id: e04b0eb9-83b5-4b33-a1e7-1c1e84f0c897
CB080F88-6B48-7021-8876-4F288E2998FDb52e2905-f906-4c46-bb24-2c7754c5d75b2008-12-15Warnings, Adverse reactionsExact identifier
spl id: CB080F88-6B48-7021-8876-4F288E2998FD
spl set id: b52e2905-f906-4c46-bb24-2c7754c5d75b

Reported adverse events (FAERS/openFDA)#

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