FDA.reportPublic FDA data

NDC 64019-554-67 - Methadone Hydrochloride

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
64019-554
Requested NDC
64019-554-67
Package NDCs from labels
64019-554-67
Manufacturer
Cebert Pharmaceuticals, Inc.
Effective date
2007-09-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methadone Hydrochloride - Cebert Pharmaceuticals, Inc.Cebert Pharmaceuticals, Inc.2007-09-16Human prescription drug label
Methadone Hydrochloride - Cebert Pharmaceuticals, Inc.Cebert Pharmaceuticals, Inc.2007-09-16Human prescription drug label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64019-554-67Methadone Hydrochloride946 mL in 1 BOTTLECONCENTRATE9461
64019-554-67Methadone Hydrochloride946 mL in 1 BOTTLECONCENTRATE9461

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64019-554METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]11 package rows20070928_DA0A54C6-8B53-4774-8C40-E615AC8D804D.zip
64019-554METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]11 package rows20070928_5E70E915-B946-4A80-BCC6-3F49BC30F2F5.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
CITRIC ACIDINACTIVE INGREDIENT2968PHW8QPMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
D&C Red #33INACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
D&C Red #33INACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
FD&C Red #40INACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
FD&C Red #40INACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
FLAVORINACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
FLAVORINACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SODIUM SACCHARININACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SODIUM SACCHARININACTIVE INGREDIENTMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
SUCROSEINACTIVE INGREDIENTC151H8M554METHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT PHARMACEUTICALS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RMETHADONE HYDROCHLORIDE (METHADONE HYDROCHLORIDE) CONCENTRATE [CEBERT 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 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDESpecGx LLC14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab582026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone HydrochlorideMETHADONE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.d7b30c78-c531-4dc5-9552-d68daa3210d12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
METHADOSEMETHADONE HYDROCHLORIDESpecGx LLC808a9d0b-720b-4034-a862-5122ff5146082026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepack714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepackf9dad5d5-3417-4992-99ee-6550f81add6b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d0e6a966-179a-45e0-8444-4c1b8523f8d22026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USAe72841bf-364b-49b1-8e69-7e26ddcd26572026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDELannett Company, Inc.0955ea4a-c6b8-431f-ba42-9641b5b102ea2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEAtlantic Biologicals Corp.373c649e-798d-770e-e063-6294a90a6e472025-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 991147
6AF99F02-AE0A-10CF-357E-AF04F97F3818DA0A54C6-8B53-4774-8C40-E615AC8D804D2007-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 6AF99F02-AE0A-10CF-357E-AF04F97F3818
spl set id: DA0A54C6-8B53-4774-8C40-E615AC8D804D
BD982412-B31A-C8FF-97B0-BD9E432344655E70E915-B946-4A80-BCC6-3F49BC30F2F52007-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: BD982412-B31A-C8FF-97B0-BD9E43234465
spl set id: 5E70E915-B946-4A80-BCC6-3F49BC30F2F5

Reported adverse events (FAERS/openFDA)#

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