Methadone Hydrochloride

Product NDC: 66689-810
11-digit product format: 666890810
Labeler code: 66689
Product ID: 66689-810_2ded4bff-215f-4f92-9931-7accd52cea65
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: VistaPharm, Inc.
Application: ANDA040241
Marketing category: ANDA
Marketing start: 1998-05-29
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: No
Listing certified through: 2020-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	66689-810		D	Discontinued by firm		2026-08-11
excluded package	package	66689-810	66689-810-10	D	Discontinued by firm		2026-08-11

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 · 24 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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`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	66689-810-10	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A040241-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL			1998-05-29
A040241-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL			1998-05-29

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1998-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1998-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	1998-05-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A040241-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040241-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040241-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040241-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040241-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040241-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040241-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040241-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040241-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040241-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040241-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040241-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040241-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040241-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040241-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040241-002	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040241-002	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040241-002	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040241-002	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040241-002	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040241-002	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040241-002	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040241-002	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040241-002	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040241-002	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040241-002	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040241-002	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040241-002	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040241-002	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040241-002	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040241-002	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040241-002	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040241-002	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040241-002	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040241-002	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040241-002	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040241-002	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040241-002	AA	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
66689-810-10	2021-05-13	C162847	48780-1	ba0f9c33-5706-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947
66689-810-10	2021-01-29	C162847	48780-1	ba0f9c33-5706-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use METHADONE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for METHADONE HYDROCHLORIDE TABLETS. METHADONE HYDROCHLORIDE tablets, for oral use, CII Initial U.S. Approval: 1947

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-810-10	EA - Each	66689-810	bc0229b4-b84f-411b-98ae-f14e6ab530ec	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHADONE HYDROCHLORIDE	ACTIVE INGREDIENT	229809935B	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
SUCROSE	INACTIVE INGREDIENT	C151H8M554	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	15

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	VistaPharm, LLC	4c8b541c-33e8-4969-b258-af150808d46e	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040241 application number: ANDA040241