Methadone Hydrochloride

Product NDC: 66689-820
11-digit product format: 666890820
Labeler code: 66689
Product ID: 66689-820_ff2d657c-1e8a-4045-95e8-b02ed45a9404
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: VistaPharm, LLC
Application: ANDA040241
Marketing category: ANDA
Marketing start: 2018-11-22
Marketing end: 2027-02-28
Substance: METHADONE HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Current FDA listing: Yes

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
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 · 84 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
2026-08-18 06:07:40	2026-07	A040241-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL		1998-05-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040241-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL		1998-05-29	`caaa826d4ba7…`
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…`

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Methadone Hydrochloride

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHADONE HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
229809935B	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
864706	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4c8b541c-33e8-4969-b258-af150808d46e	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66689-820-10	Methadone Hydrochloride	100 in 1 BOTTLE	TABLET	100		15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66689-820	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, LLC]	12	Current NDC, Legacy NDC, 1 package rows	20250123_4c8b541c-33e8-4969-b258-af150808d46e.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	VistaPharm, LLC	4c8b541c-33e8-4969-b258-af150808d46e	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040241 application number: ANDA040241 ndc (product): 66689-820

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	4c8b541c-33e8-4969-b258-af150808d46e	15
864706	methadone hydrochloride 10 MG Oral Tablet	SCD	4c8b541c-33e8-4969-b258-af150808d46e	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-820-10	66689082010	100 TABLET in 1 BOTTLE (66689-820-10)	100 tablet	2018-11-22	2027-02-28	No	No	Current