Methadone Hydrochloride

Product NDC: 66689-898
11-digit product format: 666890898
Labeler code: 66689
Product ID: 66689-898_41590bf9-c3ba-4e95-8463-7e44e198c4be
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: VistaPharm, LLC
Application: ANDA075082
Marketing category: ANDA
Marketing start: 1998-03-25
Substance: METHADONE HYDROCHLORIDE
Active strength: 40 mg/1
Pharmacologic classes: Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule: CII
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075082-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA		1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075082-001	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 2 · 44 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
2026-10-15 13:18:30	2026-09	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075082-001	METHADONE HYDROCHLORIDE	40MG	TABLET, FOR SUSPENSION / ORAL	AA	1998-03-25	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A075082-001	AA	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A075082-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075082-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075082-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075082-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075082-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075082-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075082-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075082-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075082-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075082-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075082-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075082-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075082-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075082-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075082-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075082-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075082-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075082-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075082-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075082-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075082-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075082-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075082-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075082-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075082-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075082-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075082-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075082-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075082-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075082-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075082-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075082-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075082-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075082-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075082-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075082-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075082-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075082-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075082-001	AA	1	`3a93d1ddd44b…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Methadone Hydrochloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHADONE HYDROCHLORIDE	40 mg/1

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
66689-898-40	Methadone Hydrochloride	100 in 1 BOTTLE	TABLET	100		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66689-898-40	EA - Each	66689-898	7461dd02-6c1b-4aa5-a200-d010edef2d6f	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.]	8
METHADONE	ACTIVE MOIETY	UC6VBE7V1Z	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	8
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	8
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66689-898	METHADONE HYDROCHLORIDE TABLET [VISTAPHARM, LLC]	20	Current NDC, Legacy NDC, 1 package rows	20241102_c54baaee-8ea4-45f5-a5c8-bb84cf86832f.zip

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
864978	methadone HCl 40 MG Tablet for Oral Suspension	PSN	c54baaee-8ea4-45f5-a5c8-bb84cf86832f	21
864978	methadone hydrochloride 40 MG Tablet for Oral Suspension	SCD	c54baaee-8ea4-45f5-a5c8-bb84cf86832f	21
864978	methadone HCl 40 MG Tablet for Oral Suspension	SY	c54baaee-8ea4-45f5-a5c8-bb84cf86832f	21

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66689-898-40	66689089840	100 TABLET in 1 BOTTLE (66689-898-40)	100 tablet	1998-03-25	0000-00-00	No	No	Current