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 7 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsc9693ad5-0fa6-4796-b20b-2021d589a1322025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.47114f60-4151-43d4-ac2d-adc49492a6792025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEPD-Rx Pharmaceuticals, Inc.ac0dd8fb-ebe1-4d02-bd0d-4f979c6e36082025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.02e233c4-48d1-456d-8fc8-f99a06ef854a2025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
AMLODIPINE BESYLATEAMLODIPINE BESYLATEQuallent Pharmaceuticals Health LLCc262dedb-1d13-4447-9355-f11e1dbbfb4d2025-10-13Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.7b5eb6bd-e953-429e-9280-07da4f7d7f472025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDELupin Pharmaceuticals, Inc.968c611b-43a7-40f0-9ed3-aa67ee88364b2025-10-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEBryant Ranch Prepack6cf5ece4-4d4e-478e-be8f-bd198c6edc5d2025-09-29Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC3ce6978a-6ab3-33a9-e063-6294a90a24a12025-08-21Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine besylate and Olmesartran medoxomilAMLODIPINE BESYLATE AND OLMESARTRAN MEDOXOMILAlembic Pharmaceuticals Inc.1eb78d80-701d-4766-98c3-feee6790de1a2025-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Olmesartan medoxomil Amlodipine and HydrochlorothiazideOLMESARTAN MEDOXOMIL AMLODIPINE AND HYDROCHLOROTHIAZIDEMacleods Pharmaceuticals Limited52c013e1-8c31-4bed-9241-e7845873ebe82025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltdc277f1d8-2ee0-4111-adb6-38998f77dede2025-07-18WarningsExact identifier
unii: L11K75P92J
Amlodipine BesylateAMLODIPINE BESYLATEDirect_Rx0c7d1f99-dfe0-7041-e063-6294a90a97052025-07-11Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Schuessler Tissue Salts Calc Phos Bone Health 2CALCAREA PHOSPHORICAMartin & Pleasance Pty Ltd81d59754-1b36-4f71-aec1-5335b003a96f2025-07-01WarningsExact identifier
unii: L11K75P92J
olmesartan medoxomil and amlodipine besylate and hydrochlorothiazideOLMESARTAN MEDOXOMIL AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDESlate Run Pharmaceuticals, LLCa469adff-25a6-4983-b471-60924d920a862025-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATENuCare Pharmaceuticals,Inc.2437a130-d544-6db4-e063-6394a90a0d4d2025-06-13Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDEAMLODIPINE BESYLATE VALSARTAN HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.e9ecbadb-c548-6fe5-e053-2a95a90a75772025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine Besylate and Benazepril HydrochlorideAMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDEBryant Ranch Prepackd058e426-8786-4fd3-a771-992e4558c1352025-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and olmesartan MedoxomilAMLODIPINE AND OLMESARTAN MEDOXOMILAscend Laboratories, LLCc1204fbe-d086-43cf-bbaa-efec9cd0487c2025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINAlembic Pharmaceuticals Inc.1346631f-e6db-4c5c-a6af-5aa7b80a011d2025-05-23Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H

Reported adverse events (FAERS/openFDA)#

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