Home NDC 0406-1510 Methadone Hydrochloride
Product NDC 0406-1510
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 NDC auxiliary status# These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
Current NDC status page 1 of 1 · 7 matching rows.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date unfinished product product 0406-1510 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0406-1510 0406-1510-06 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0406-1510 0406-1510-40 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0406-1510 0406-1510-41 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0406-1510 0406-1510-42 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0406-1510 0406-1510-56 UNFINISHED Active or certified unfinished drug listing 2026-09-14 unfinished package package 0406-1510 0406-1510-57 UNFINISHED Active or certified unfinished drug listing 2026-09-14
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 2 · 97 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Marketing end Status 0406-1510-06 00406151006 1 kg in 1 DRUM (0406-1510-06) 1 kg 30-APR-12 01-MAR-31 Historical 0406-1510-40 00406151040 .5 kg in 1 BOTTLE, GLASS (0406-1510-40) 01-JAN-25 Current 0406-1510-41 00406151041 10 kg in 1 PAIL (0406-1510-41) 10 kg 01-JAN-25 Current 0406-1510-42 00406151042 50 kg in 1 DRUM (0406-1510-42) 50 kg 01-JAN-25 Current 0406-1510-56 00406151056 .05 kg in 1 BOTTLE (0406-1510-56) 30-APR-12 Current 0406-1510-57 00406151057 .1 kg in 1 BOTTLE, GLASS (0406-1510-57) 30-APR-12 Current