FDA.reportPublic FDA data

NDC 64365-507 - AVINZA

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
64365-507
Package NDCs from labels
64365-507-02
Manufacturer
Ligand Pharmaceuticals Incorporated
Effective date
2006-08-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AVINZA - Ligand Pharmaceuticals IncorporatedLigand Pharmaceuticals Incorporated2006-08-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64365-507-02AVINZA100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64365-507AVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]11 package rows20060918_D06642A8-A26A-4007-9ED6-812C4B87F1E8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
morphine sulfateACTIVE INGREDIENTX3P646A2J0AVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
morphineACTIVE MOIETY76I7G6D29CAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
ammonio-methacrylate copolymersINACTIVE INGREDIENTAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
fumaric acidINACTIVE INGREDIENTAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
povidoneINACTIVE INGREDIENTAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
sugar starch spheresINACTIVE INGREDIENTAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]1
talcINACTIVE INGREDIENT7SEV7J4R1UAVINZA (MORPHINE SULFATE) CAPSULE, EXTENDED RELEASE [LIGAND PHARMACEUTICALS INCORPORATED]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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D06642A8-A26A-4007-9ED6-812C4B87F1E8D06642A8-A26A-4007-9ED6-812C4B87F1E82006-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: D06642A8-A26A-4007-9ED6-812C4B87F1E8
spl set id: D06642A8-A26A-4007-9ED6-812C4B87F1E8

Reported adverse events (FAERS/openFDA)#

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