FDA.reportPublic FDA data

Application 006383

Type
NDA
Sponsor
MALLINCKRODT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEPOWDER;FOR RX COMPOUNDING50GM/BOTNoNo
003METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEPOWDER;FOR RX COMPOUNDING100GM/BOTNoNo
004METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEPOWDER;FOR RX COMPOUNDING500GM/BOTNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N006383-002METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982
N006383-003METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982
N006383-004METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982caaa826d4ba7…
2026-08-18 06:07:402026-07N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N006383-003METHADONE HYDROCHLORIDE100GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N006383-004METHADONE HYDROCHLORIDE500GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N006383-002METHADONE HYDROCHLORIDE50GM/BOTPOWDER / FOR RX COMPOUNDINGApproved before 19821e350fbaab3a…

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
METHADOSE DISPERSIBLEMETHADONE HYDROCHLORIDESpecGx LLC544483e6-6f9d-4371-9e93-313e54e0ea052026-08-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHADONE HYDROCHLORIDE
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAmerican Health Packaging540edd43-165d-4257-b989-3bccc8f54afb2026-08-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDESpecGx LLC14f7b1d8-344a-4eaa-a1bf-bc1a00c3ab582026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDEMajor Pharmaceuticalsdb52fdc0-765a-4fad-a8f9-ef98c6e4b8982026-07-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHADONE HYDROCHLORIDE
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEATLANTIC BIOLOGICALS CORP.d7b30c78-c531-4dc5-9552-d68daa3210d12026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDELong Grove Pharmaceuticals, LLCf453f1b9-d46e-4be8-835d-dbeb9d98a1492026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEBreckenridge Pharmaceutical Inc13541167-95f4-4cb9-9d7d-3c1aced5c5f62026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLC5baef1bf-8bf0-429c-a4ce-1c93171f3f152026-04-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHADONE HYDROCHLORIDE
generic name: METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESpecGx LLCeddf7077-02fb-4771-9823-31984f4ff2bb2026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METHADONE HYDROCHLORIDE
generic name: METHADONE HYDROCHLORIDE
METHADOSEMETHADONE HYDROCHLORIDESpecGx LLC808a9d0b-720b-4034-a862-5122ff5146082026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepack714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEAscend Laboratories, LLCf0366917-f745-4b01-a662-a98a7d80b4a02026-04-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDEBryant Ranch Prepackf9dad5d5-3417-4992-99ee-6550f81add6b2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLC7ff89589-149c-4007-8144-5f60131b8c332026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.d0e6a966-179a-45e0-8444-4c1b8523f8d22026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEHikma Pharmaceuticals USAe72841bf-364b-49b1-8e69-7e26ddcd26572026-03-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCd5bd3e97-b3f6-4bc2-9fb7-02921be35cdb2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEVistaPharm, LLCc54baaee-8ea4-45f5-a5c8-bb84cf86832f2026-01-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE
Methadone Hydrocloride dye-free, sugar-free, unflavoredMETHADONE HYDROCHLORIDELannett Company, Inc.0955ea4a-c6b8-431f-ba42-9641b5b102ea2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METHADONE HYDROCHLORIDE
Methadone HydrochlorideMETHADONE HYDROCHLORIDEMylan Institutional LLC092d78eb-6423-495c-bf0d-e6532bea71382025-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Methadone Hydrochloride
generic name: METHADONE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0406-1510Methadone HydrochlorideMethadone HydrochlorideMallinckrodt, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52283SUPPL2018-02-02
52252SUPPL2018-02-01
46418SUPPL2016-12-21
46198SUPPL2016-12-19