FDA.reportPublic FDA data

NDC 57664-569 - 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
57664-569
Package NDCs from labels
57664-569-99, 57664-569-88, 57664-569-13, 57664-569-18
Manufacturer
CARACO PHARMACEUTICAL LABORATORIES, LTD.
Effective date
2008-12-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
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
57664-569-13Amlodipine500 in 1 BOTTLETABLET5001
57664-569-18Amlodipine1000 in 1 BOTTLETABLET10001
57664-569-88Amlodipine100 in 1 BOTTLETABLET1001
57664-569-99Amlodipine90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57664-569AMLODIPINE (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
57664-569-13EA - Each57664-56916785f0f-d993-40b4-86a5-5ada750be53012013-02-13
57664-569-18EA - Each57664-5695df3b1d9-e39c-4fb8-af53-d9f8d8a869a412013-02-13
57664-569-99EA - Each57664-569a04536fe-5362-4bc9-b359-6b1d0745457812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
AmlodipineACTIVE MOIETY1J444QC288AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
dibasic calcium phosphateINACTIVE INGREDIENTAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]1
sodium starch glycolateINACTIVE INGREDIENTAMLODIPINE (AMLODIPINE BESYLATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]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 7 · 124 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMLODIPINE BESYLATEAMLODIPINE BESYLATEProficient Rx LP410aa0a5-43cf-455c-b51d-7dfbc24eee322020-02-01Warnings, Adverse reactionsExact identifier
rxcui: 308135
NorvascAMLODIPINE BESYLATEPFIZER LABORATORIES DIV PFIZER INCabd6a2ca-40c2-485c-bc53-db1c652505ed2019-01-15Warnings, Adverse reactionsExact identifier
rxcui: 197361
rxcui: 308136
rxcui: 308135
Amlodipine besylateAMLODIPINE BESYLATEAphena Pharma Solutions - Tennessee, LLC17e6d552-7528-4597-9498-104cb04f32e72017-10-25Warnings, Adverse reactionsExact identifier
rxcui: 308135
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.