METHADONE HYDROCHLORIDE

Product NDC: 52959-386
11-digit product format: 529590386
Labeler code: 52959
Product ID: 52959-386_8a7832fd-a24f-43b5-b46c-6043dfb24114
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: METHADONE HYDROCHLORIDE
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company Inc.
Application: ANDA040517
Marketing category: ANDA
Marketing start: 2009-05-19
Marketing end: 0000-00-00
Substance: METHADONE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52959-386		I	Inactivated by FDA	2026-08-17
excluded package	package	52959-386	52959-386-02	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-386	52959-386-30	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-386	52959-386-60	I	Inactivated by FDA	2026-08-17
excluded package	package	52959-386	52959-386-90	I	Inactivated by FDA	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 2 · 110 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-386-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-386-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-386-90	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52959-386-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-386-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-386-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-386-90	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52959-386-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-386-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-386-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-386-90	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52959-386-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-386-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-386-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-386-90	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52959-386-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-386-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-386-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-386-90	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52959-386-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-386-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-386-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-386-90	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52959-386-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-386-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-386-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-386-90	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52959-386-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-386-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-386-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-386-90	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52959-386-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-386-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-386-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-386-90	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52959-386-02	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-386-60	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-386-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-386-90	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52959-386-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-386-60	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-386-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-386-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52959-386-02	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-386-60	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-386-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-386-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52959-386-02	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040517-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27
A040517-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A040517-001	AA
A040517-002	AA

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 3 · 84 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
2026-08-18 06:07:40	2026-07	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2004-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2004-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040517-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	RS	2004-04-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040517-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	RS	2004-04-27	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040517-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040517-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040517-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040517-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040517-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040517-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040517-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040517-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040517-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040517-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040517-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040517-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040517-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040517-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040517-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040517-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040517-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040517-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040517-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040517-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040517-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040517-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040517-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040517-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040517-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040517-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040517-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040517-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040517-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040517-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040517-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040517-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040517-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040517-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040517-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040517-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040517-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040517-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040517-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040517-002	AA	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bc6c52c8-e3e2-9042-21d0-6770dcf1a49b	Product name	3	20250819
a48f0261-b6cc-12b3-49fd-ed131bc5aa96	Product name	4	20210902
00dcb24c-d95e-78f6-6c1b-4d7b709bb2b9	Product name	6	20200708
a6a96832-f31d-b458-45cb-abb8bd940b44	Product name	2	20200304

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
52959-386-02	METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only
52959-386-30	METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only
52959-386-60	METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only
52959-386-90	METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52959-386-02	METHADONE HYDROCHLORIDE	120 in 1 BOTTLE	TABLET	120	3
52959-386-30	METHADONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET	30	3
52959-386-60	METHADONE HYDROCHLORIDE	60 in 1 BOTTLE	TABLET	60	3
52959-386-90	METHADONE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET	90	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52959-386-02	EA - Each	52959-386	691de44f-cb34-4031-8408-a08fc1c1e208	1	2012-07-24
52959-386-30	EA - Each	52959-386	6c3d8898-7777-42f2-b7c7-0e88e5ce25b3	1	2012-07-24
52959-386-60	EA - Each	52959-386	f728ec4d-8695-4741-8730-e7fc8f3b4f07	1	2012-07-24
52959-386-90	EA - Each	52959-386	348c0e2a-d9af-4885-9a77-e3c67dddda28	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52959-386	METHADONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY INC.]	3	Legacy NDC, 4 package rows	20111212_3c926b78-999e-4d26-9498-7f1bcaf0b992.zip

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	SpecGx LLC	eddf7077-02fb-4771-9823-31984f4ff2bb	2026-04-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040517 application number: ANDA040517

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
864706	methadone HCl 10 MG Oral Tablet	PSN	3c926b78-999e-4d26-9498-7f1bcaf0b992	3
864718	methadone HCl 5 MG Oral Tablet	PSN	3c926b78-999e-4d26-9498-7f1bcaf0b992	3
864706	methadone hydrochloride 10 MG Oral Tablet	SCD	3c926b78-999e-4d26-9498-7f1bcaf0b992	3
864718	methadone hydrochloride 5 MG Oral Tablet	SCD	3c926b78-999e-4d26-9498-7f1bcaf0b992	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
52959-386-02	52959038602	120 in 1 BOTTLE	Historical
52959-386-30	52959038630	30 in 1 BOTTLE	Historical
52959-386-60	52959038660	60 in 1 BOTTLE	Historical
52959-386-90	52959038690	90 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
METHADONE HYDROCHLORIDE TABLETS USP 5 mg, 10 mg CII Rx only	H.J. Harkins Company Inc. \| Mallinckrodt Inc.	2011-12-08	HUMAN PRESCRIPTION DRUG LABEL	3