Methadone Hydrochloride

Product NDC: 60687-910
11-digit product format: 606870910
Labeler code: 60687
Product ID: 60687-910_5b1344a0-2ae2-1751-e063-6394a90a46fe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methadone Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA211228
Marketing category: ANDA
Marketing start: 2026-09-09
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A211228-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA		2019-01-03
A211228-002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA		2019-01-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211228-001	AA
A211228-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211228-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211228-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211228-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211228-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211228-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211228-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211228-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211228-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211228-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211228-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211228-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211228-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211228-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211228-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211228-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211228-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211228-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211228-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211228-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211228-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211228-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211228-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211228-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211228-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211228-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211228-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211228-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211228-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211228-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211228-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211228-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211228-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211228-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211228-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211228-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211228-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211228-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211228-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211228-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211228-002	AA	1	`74a2ff9319b5…`

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	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
540edd43-165d-4257-b989-3bccc8f54afb	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	American Health Packaging	540edd43-165d-4257-b989-3bccc8f54afb	2026-09-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211228 application number: ANDA211228 ndc (product): 60687-910
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	Camber Pharmaceuticals, Inc	8f4cf84e-165c-489d-a668-0f715053f196	2025-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211228 application number: ANDA211228
Methadone Hydrochloride	METHADONE HYDROCHLORIDE	XLCare Pharmaceuticals, Inc	1a536622-dda3-41af-ab08-28e7c1bc9300	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211228 application number: ANDA211228

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	Sample	Exclude flag	Status
60687-910-01	60687091001	100 BLISTER PACK in 1 CARTON (60687-910-01) / 1 TABLET in 1 BLISTER PACK (60687-910-11)	100 blister pack	2026-09-09	No	No	Current