Application 076264

Type: ANDA
Sponsor: SPECGX LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	TABLET;ORAL	25MG	No	No
002	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	Yes
003	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	TABLET;ORAL	100MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076264-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22
A076264-002	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22
A076264-003	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076264-002	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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A076264-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076264-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076264-002	AB	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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	SpecGx LLC	06ff2d5a-e62b-4fa4-bbdb-01938535bc65	2026-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264 ndc (product): 0406-1170
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	43cd6961-4793-85ee-e063-6294a90ad772	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	0103a32b-14a9-48a8-8952-b2b12ef09649	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	3cbd0cad-7c56-ac0a-e063-6294a90a80e4	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390bff41-7bab-b72a-e063-6294a90ad35d	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	American Health Packaging	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264 ndc (product): 68084-291
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	838a1e88-1179-4a2a-a737-8ce008bb96a7	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264 ndc (product): 71335-1480
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	10261f2f-e4c1-415c-b722-edeaab97a112	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264

Reported adverse events (FAERS/openFDA)#

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

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
0406-1170	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	SpecGx LLC	ANDA	Current
0406-1170	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	SpecGx LLC	ANDA	Current
0406-1170	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	SpecGx LLC	ANDA	Current
0406-1170	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	SpecGx LLC	ANDA	Current
68084-291	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	American Health Packaging	ANDA	Current
68084-291	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	American Health Packaging	ANDA	Current
68084-291	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	American Health Packaging	ANDA	Current
68084-291	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	American Health Packaging	ANDA	Current
70518-1312	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1312	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-1312	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-1480	NALTREXONE HYDROCHLORIDE	naltrexone hydrochloride	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22552	ORIG	2007-05-09
8882	ORIG	2003-04-11