FDA.reportPublic FDA data

NDC 0406-1510-59 - 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
0406-1510
Requested NDC
0406-1510-59
Package NDCs from labels
0406-1510-56, 0406-1510-57, 0406-1510-59
Manufacturer
Mallinckrodt, Inc.
Effective date
2017-09-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Methadone Hydrochloride USP POWDER CII FOR ORAL USE ONLYMallinckrodt, Inc.2017-09-11HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-1510-56GM - Gram0406-15109a0ab592-1130-4db2-9c89-0df6150dc00a12013-02-13
0406-1510-57GM - Gram0406-1510184f2761-3774-4fdc-992d-efb0cfd04d2f12013-02-13
0406-1510-59GM - Gram0406-1510eef8a79f-81a6-4233-b121-ac37702fa35412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHADONE HYDROCHLORIDEACTIVE INGREDIENT229809935BMETHADONE HYDROCHLORIDE POWDER [MALLINCKRODT, INC.]6
METHADONEACTIVE MOIETYUC6VBE7V1ZMETHADONE HYDROCHLORIDE POWDER [MALLINCKRODT, INC.]6

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAmerican Health Packaging540edd43-165d-4257-b989-3bccc8f54afb2026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADOSE DISPERSIBLEMETHADONE HYDROCHLORIDESpecGx LLC544483e6-6f9d-4371-9e93-313e54e0ea052026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDESpecGx LLC14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab582026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEMajor Pharmaceuticalsdb52fdc0-765a-4fad-a8f9-ef98c6e4b8982026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.d7b30c78-c531-4dc5-9552-d68daa3210d12026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDELong Grove Pharmaceuticals, LLCf453f1b9-d46e-4be8-835d-dbeb9d98a1492026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEBreckenridge Pharmaceutical Inc13541167-95f4-4cb9-9d7d-3c1aced5c5f62026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLC5baef1bf-8bf0-429c-a4ce-1c93171f3f152026-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLCeddf7077-02fb-4771-9823-31984f4ff2bb2026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
METHADOSEMETHADONE HYDROCHLORIDESpecGx LLC808a9d0b-720b-4034-a862-5122ff5146082026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepack714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe2026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAscend Laboratories, LLCf0366917-f745-4b01-a662-a98a7d80b4a02026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepackf9dad5d5-3417-4992-99ee-6550f81add6b2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLC7ff89589-149c-4007-8144-5f60131b8c332026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d0e6a966-179a-45e0-8444-4c1b8523f8d22026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USAe72841bf-364b-49b1-8e69-7e26ddcd26572026-03-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDELannett Company, Inc.0955ea4a-c6b8-431f-ba42-9641b5b102ea2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONE HYDROCHLORIDEMylan Institutional LLC092d78eb-6423-495c-bf0d-e6532bea71382025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B
Methadone HydrochlorideMETHADONEVistaPharm, LLC4a44bde6-c348-4316-b0e0-c24b407cb8232025-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 229809935B

Reported adverse events (FAERS/openFDA)#

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