FDA.reportPublic FDA data

NDC 63672-0045 - Amlodipine Besylate

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
63672-0045
Package NDCs from labels
63672-0045-3
Manufacturer
Synthon Pharmaceuticals, Inc.
Effective date
2008-01-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Amlodipine Besylate TabletsSynthon Pharmaceuticals, Inc.2008-01-23HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63672-0045-3Amlodipine Besylate90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63672-0045AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]11 package rows20080130_6E9A6C82-9F25-4C71-B09A-929BD5D7B1CF.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63672-0045-3EA - Each63672-0045c38a51c4-388e-415c-a7ad-7a65cbb7862312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Amlodipine besylateACTIVE INGREDIENT864V2Q084HAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
AmlodipineACTIVE MOIETY1J444QC288AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30AMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]1
sodium starch glycolateINACTIVE INGREDIENTAMLODIPINE BESYLATE (AMLODIPINE BESYLATE) TABLET [SYNTHON PHARMACEUTICALS, INC.]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
7ABC4DB9-AADA-7A24-9BF4-DC0D0B06E1806E9A6C82-9F25-4C71-B09A-929BD5D7B1CF2008-01-23Warnings, Adverse reactionsExact identifier
spl id: 7ABC4DB9-AADA-7A24-9BF4-DC0D0B06E180
spl set id: 6E9A6C82-9F25-4C71-B09A-929BD5D7B1CF

Reported adverse events (FAERS/openFDA)#

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