Application 212093

Type: ANDA
Sponsor: LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	UNKNOWN	UNKNOWN	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A212093-001	METHADONE HYDROCHLORIDE	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA		2020-11-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212093-001	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.

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	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212093-001	METHADONE HYDROCHLORIDE	10MG/ML	CONCENTRATE / ORAL	AA	2020-11-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212093-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212093-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212093-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212093-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212093-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212093-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212093-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212093-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212093-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212093-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212093-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212093-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212093-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212093-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212093-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212093-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212093-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212093-001	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212093-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212093-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212093-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212093-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212093-001	AA	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212093-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212093-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212093-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212093-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212093-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212093-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212093-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212093-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212093-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212093-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212093-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212093-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212093-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212093-001	AA	1	`a50c72e98297…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	714e5adb-bdce-4dff-99aa-4ac3a2f3a0fe	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Bryant Ranch Prepack	f9dad5d5-3417-4992-99ee-6550f81add6b	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093 ndc (product): 63629-2098
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Lannett Company, Inc.	0955ea4a-c6b8-431f-ba42-9641b5b102ea	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093 ndc (product): 0527-1927
Methadone Hydrocloride dye-free, sugar-free, unflavored	METHADONE HYDROCHLORIDE	Atlantic Biologicals Corp.	373c649e-798d-770e-e063-6294a90a6e47	2025-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212093 application number: ANDA212093 ndc (product): 17856-1927

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0527-1927	Methadone Hydrocloride	methadone hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1927	Methadone Hydrocloride	methadone hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1927	Methadone Hydrocloride	methadone hydrochloride	Lannett Company, Inc.	ANDA	Current
0527-1927	Methadone Hydrocloride	methadone hydrochloride	Lannett Company, Inc.	ANDA	Current
17856-1927	Methadone Hydrocloride	methadone hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1927	Methadone Hydrocloride	methadone hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1927	Methadone Hydrocloride	methadone hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1927	Methadone Hydrocloride	methadone hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
17856-1928	Methadone Hydrocloride	methadone hydrochloride	ATLANTIC BIOLOGICALS CORP.	ANDA	Current
63629-2098	Methadone Hydrocloride	methadone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2098	Methadone Hydrocloride	methadone hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-2098	Methadone Hydrocloride	methadone hydrochloride	Bryant Ranch Prepack	ANDA	Current