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 11 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amlodipine BesylateAMLODIPINE BESYLATETeva Pharmaceuticals, Inc.47edc328-2444-4ca1-a5c1-7c83141e105c2024-03-01Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackb404a550-0df4-404a-8d10-c35e197ca3992024-02-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack44dc874b-4377-46eb-ae32-8d84c9c4d4ae2024-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepack498a9b21-34b9-4373-930b-5ed43201a3452024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEBryant Ranch Prepacke8958997-f098-44ce-8c21-b7064d1a962e2024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions55bfd9ea-b474-4863-8fae-1b720d91034c2024-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Telmisartan and AmlodipineTELMISARTAN AND AMLODIPINELupin Pharmaceuticals, Inc.a97fefa6-99e6-4eb7-9393-ab2252a2c7d82023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine, Valsartan and HydrochlorothiazideAMLODIPINE, VALSARTAN AND HYDROCHLOROTHIAZIDELupin Pharmaceuticals, Inc.5dbb43b1-3ea4-4fa5-a9aa-95d869ae65fe2023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine and ValsartanAMLODIPINE AND VALSARTANLupin Pharmaceuticals, Inc.35086164-bf92-4b3c-9845-f8cd7464c7d62023-12-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack900024f4-23d6-4505-81db-4f643e12858c2023-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions5c50c3fe-afe5-459e-95c0-c9af4cbb69092023-11-13Warnings, Adverse reactionsExact identifier
rxcui: 308135
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutions89d8d490-3a9c-40f2-86b7-94b5101dd09a2023-10-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEA-S Medication Solutions4512feee-a09d-4244-bc03-c43193e53a0e2023-09-20Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
Amlodipine and Benazepril HydrochlorideAMLODIPINE AND BENAZEPRIL HYDROCHLORIDEA-S Medication Solutionsf77db79c-c998-4b63-9984-4cf245f188a72023-09-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 864V2Q084H
Amlodipine BesylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLCd830173d-7676-4490-ab3d-d3515df9ad2e2023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 308136
unii: 864V2Q084H
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC5dfcba1f-91c4-4ca5-8a98-fc4fdb2f7ee12023-09-07Warnings, Adverse reactionsExact identifier
rxcui: 197361
unii: 864V2Q084H
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 1P9D0Z171K
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
unii: 1P9D0Z171K
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: 1P9D0Z171K

Reported adverse events (FAERS/openFDA)#

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