Application 211228

Type: ANDA
Sponsor: ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

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
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 · 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	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…`
2022-03-09 01:35 UTC	2022-03	A211228-001	METHADONE HYDROCHLORIDE	5MG	TABLET / ORAL	AA	2019-01-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211228-002	METHADONE HYDROCHLORIDE	10MG	TABLET / ORAL	AA	2019-01-03	`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	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…`
2022-03-09 01:35 UTC	2022-03	A211228-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211228-002	AA	1	`bb7c543d1eb4…`

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	2026-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211228 application number: ANDA211228
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 ndc (product): 31722-947 ndc (product): 31722-946
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 ndc (product): 72865-120 ndc (product): 72865-121

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-946	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-946	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-946	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-946	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-947	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-947	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-947	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
31722-947	Methadone Hydrochloride	Methadone Hydrochloride	Camber Pharmaceuticals, Inc	ANDA	Current
63629-1905	Methadone Hydrochloride	Methadone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1905	Methadone Hydrochloride	Methadone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1905	Methadone Hydrochloride	Methadone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1906	Methadone Hydrochloride	Methadone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1906	Methadone Hydrochloride	Methadone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1906	Methadone Hydrochloride	Methadone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
72865-120	Methadone Hydrochloride	Methadone Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current
72865-121	Methadone Hydrochloride	Methadone Hydrochloride	XLCare Pharmaceuticals, Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76434	ORIG	2023-11-07