Home NDC 0406-1510-41 Methadone Hydrochloride
Product NDC 0406-1510
Requested package NDC 0406-1510-41
11-digit product format 004061510
Labeler code 0406
Product ID 0406-1510_fb536c3e-1f0b-4364-b83a-a83d190f59db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methadone Hydrochloride
Dosage form POWDER
Route ORAL
Labeler Mallinckrodt, Inc.
Application NDA006383
Marketing category NDA
Marketing start 2012-04-30
Marketing end 2023-05-31
Substance METHADONE HYDROCHLORIDE
Active strength 1 g/g
Pharmacologic classes Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule CII
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record
Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 8 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N006383-002 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 N006383-003 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 N006383-004 METHADONE HYDROCHLORIDE METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved 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 · 129 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 84e616aacf4f…2026-09-14 22:38:34 2026-08 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N006383-003 METHADONE HYDROCHLORIDE 100GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N006383-004 METHADONE HYDROCHLORIDE 500GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N006383-002 METHADONE HYDROCHLORIDE 50GM/BOT POWDER / FOR RX COMPOUNDING Approved before 1982 301d65b070ca…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product No
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHADONE HYDROCHLORIDE 1 kg/kg
DailyMed Socrata Ingredients# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0406-1510-41 00406151041 10 kg in 1 PAIL (0406-1510-41) 10 kg 01-JAN-25 Current