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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct0406-1510UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0406-15100406-1510-06UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0406-15100406-1510-40UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0406-15100406-1510-41UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0406-15100406-1510-42UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0406-15100406-1510-56UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0406-15100406-1510-57UNFINISHEDActive or certified unfinished drug listing2026-08-17

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.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0406-1510-06a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0406-1510-41a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0406-1510-40a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0406-1510-42a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0406-1510-56a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0406-1510-57a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0406-1510-061d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0406-1510-411d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0406-1510-401d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0406-1510-421d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0406-1510-561d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0406-1510-571d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0406-1510-06390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0406-1510-41390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0406-1510-40390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0406-1510-42390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0406-1510-56390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0406-1510-57390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0406-1510-06e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0406-1510-41e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0406-1510-40e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0406-1510-42e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0406-1510-56e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0406-1510-57e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0406-1510-06bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0406-1510-41bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0406-1510-40bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0406-1510-42bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0406-1510-56bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0406-1510-57bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0406-1510-06f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0406-1510-41f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0406-1510-40f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0406-1510-42f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0406-1510-56f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0406-1510-57f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0406-1510-06f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0406-1510-41f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0406-1510-40f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0406-1510-42f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0406-1510-56f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0406-1510-57f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0406-1510-4068b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0406-1510-4168b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0406-1510-0668b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0406-1510-5668b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0406-1510-5768b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0406-1510-4268b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0406-1510-0605c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0406-1510-5605c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0406-1510-5705c55d027831…ca05dca9dc4c…

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…

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHADONE HYDROCHLORIDE1 kg/kg

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endStatus
0406-1510-06004061510061 kg in 1 DRUM (0406-1510-06)1 kg30-APR-1201-MAR-31Historical
0406-1510-4000406151040.5 kg in 1 BOTTLE, GLASS (0406-1510-40)01-JAN-25Current
0406-1510-410040615104110 kg in 1 PAIL (0406-1510-41)10 kg01-JAN-25Current
0406-1510-420040615104250 kg in 1 DRUM (0406-1510-42)50 kg01-JAN-25Current
0406-1510-5600406151056.05 kg in 1 BOTTLE (0406-1510-56)30-APR-12Current
0406-1510-5700406151057.1 kg in 1 BOTTLE, GLASS (0406-1510-57)30-APR-12Current