Application 091205

Type: ANDA
Sponsor: ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091205-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2011-08-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091205-001	AB

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 · 41 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
2026-02-19 14:30 UTC	2026-02	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091205-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2011-08-17	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091205-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091205-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091205-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091205-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091205-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091205-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091205-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091205-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091205-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091205-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091205-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091205-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091205-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091205-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091205-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091205-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091205-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091205-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091205-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091205-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091205-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091205-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091205-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091205-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091205-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091205-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091205-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091205-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091205-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091205-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091205-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091205-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091205-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091205-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091205-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091205-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091205-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091205-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091205-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091205-001	AB	1	`cb3db0bc1861…`

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
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Redpharm Drug	57439bad-00f0-5696-e063-6294a90a2ea5	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091205 application number: ANDA091205
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	fa0b0881-97f3-4ca2-bc15-0954293081db	2026-05-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091205 application number: ANDA091205 ndc (product): 71335-0014
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Accord Healthcare, Inc.	49aa3d6d-2270-4615-aafa-b440859ab870	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091205 application number: ANDA091205 ndc (product): 16729-081
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	00c04ff4-b6f2-466c-9ab9-813a60577db0	2023-12-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091205 application number: ANDA091205 ndc (product): 50090-4925

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16729-081	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Accord Healthcare, Inc.	ANDA	Current
50090-4925	Naltrexone Hydrochloride	Naltrexone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4925	Naltrexone Hydrochloride	Naltrexone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-4926	Naltrexone Hydrochloride	Naltrexone Hydrochloride	A-S Medication Solutions	ANDA	Current
68071-2721	Naltrexone Hydrochloride	Naltrexone Hydrochloride	NuCare Pharmceuticals,Inc.	ANDA	Current
68788-7084	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-1146	Naltrexone Hydrochloride	Naltrexone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1146	Naltrexone Hydrochloride	Naltrexone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1146	Naltrexone Hydrochloride	Naltrexone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1146	Naltrexone Hydrochloride	Naltrexone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1146	Naltrexone Hydrochloride	Naltrexone Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0014	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0014	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current