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

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	0406-1510	0406-1510-41	UNFINISHED	Active or certified unfinished drug listing		2026-08-17

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 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 42.

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	RLD / RS
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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006383-003	METHADONE HYDROCHLORIDE	100GM/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N006383-004	METHADONE HYDROCHLORIDE	500GM/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N006383-002	METHADONE HYDROCHLORIDE	50GM/BOT	POWDER / FOR RX COMPOUNDING	Approved before 1982	`1e350fbaab3a…`

Additional Listing Data#

Finished product: No
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHADONE HYDROCHLORIDE	1 kg/kg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0406-1510-56	GM - Gram	0406-1510	9a0ab592-1130-4db2-9c89-0df6150dc00a	1	2013-02-13
0406-1510-57	GM - Gram	0406-1510	184f2761-3774-4fdc-992d-efb0cfd04d2f	1	2013-02-13
0406-1510-59	GM - Gram	0406-1510	eef8a79f-81a6-4233-b121-ac37702fa354	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	METHADONE HYDROCHLORIDE POWDER [MALLINCKRODT, INC.]	6
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADONE HYDROCHLORIDE POWDER [MALLINCKRODT, INC.]	6

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
229809935B	METHADONE HYDROCHLORIDE	1095-90-5	METHADONE HYDROCHLORIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Methadone Hydrochloride USP POWDER CII FOR ORAL USE ONLY	Mallinckrodt, Inc.	2017-09-11	HUMAN PRESCRIPTION DRUG LABEL	12