FDA.reportPublic FDA data

NDC 66479-530 - Methadone

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
66479-530
Package NDCs from labels
66479-530-02
Manufacturer
Xanodyne Pharmaceuticals Inc.
Effective date
2007-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
METHADONE HYDROCHLORIDE INJECTION, USPXanodyne Pharmaceuticals Inc.2007-10-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66479-530-02Methadone20 mL in 1 VIALINJECTION, SOLUTION201
66479-530-02Methadone1 in 1 PACKAGEINJECTION, SOLUTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66479-530METHADONE (METHADONE HYDROCHLORIDE) INJECTION, SOLUTION [XANODYNE PHARMACEUTICALS INC.]12 package rows20071019_9bbe219f-3bf1-44f4-a709-cd108c4fa9ef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
methadone hydrochlorideACTIVE INGREDIENT229809935BMETHADONE (METHADONE HYDROCHLORIDE) INJECTION, SOLUTION [XANODYNE PHARMACEUTICALS INC.]1
methadoneACTIVE MOIETYUC6VBE7V1ZMETHADONE (METHADONE HYDROCHLORIDE) INJECTION, SOLUTION [XANODYNE PHARMACEUTICALS INC.]1
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCMETHADONE (METHADONE HYDROCHLORIDE) INJECTION, SOLUTION [XANODYNE PHARMACEUTICALS INC.]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XMETHADONE (METHADONE HYDROCHLORIDE) INJECTION, SOLUTION [XANODYNE 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 1 of 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDELong Grove Pharmaceuticals, LLCf453f1b9-d46e-4be8-835d-dbeb9d98a1492026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864714
Methadone HydrochlorideMETHADONE HYDROCHLORIDEBreckenridge Pharmaceutical Inc13541167-95f4-4cb9-9d7d-3c1aced5c5f62026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864714
Methadone HydrochlorideMETHADONE HYDROCHLORIDEMylan Institutional LLC092d78eb-6423-495c-bf0d-e6532bea71382025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864714
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.1a6dbcb0-68f2-4f8b-94ee-baa2aa2962932025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 864714
3DF4A22E-18AB-BEDA-263A-DB02D0BD7C5A9bbe219f-3bf1-44f4-a709-cd108c4fa9ef2007-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 3DF4A22E-18AB-BEDA-263A-DB02D0BD7C5A
spl set id: 9bbe219f-3bf1-44f4-a709-cd108c4fa9ef

Reported adverse events (FAERS/openFDA)#

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