Application 074918

Type: ANDA
Sponsor: BARR

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 43.

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
A074918-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1998-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074918-001	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 · 43 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	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`f41ea6bd6efb…`

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	A074918-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074918-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074918-001	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 3 · 44 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	db911559-26f5-43a0-b61f-3425176c936f	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	SpecGx LLC	06ff2d5a-e62b-4fa4-bbdb-01938535bc65	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	f821dd49-3fa7-4d33-99de-19023ff1ae65	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Redpharm Drug	57439bad-00f0-5696-e063-6294a90a2ea5	2026-07-23	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	f9807ec0-3504-4c66-8efe-ea25f84c782b	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Major Pharmaceuticals	69cb8573-08c1-4957-a768-6cd383f6a3f4	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Chartwell RX, LLC	adb7c4dc-221a-4d91-9687-0d78913a92ad	2026-06-19	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Coupler LLC	544f79a7-ca89-795d-e063-6294a90a8a97	2026-06-15	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	0f30f885-d0cd-4fa6-a8e0-142f08a56792	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Coupler LLC	56055980-d23b-ec7d-e063-6394a90a9cc2	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Elite Laboratories, Inc.	5f188bdc-2009-43aa-ad32-f06dbfac2642	2026-05-21	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	fa0b0881-97f3-4ca2-bc15-0954293081db	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	ab5b3829-96e5-4123-967a-29b41f13a4f7	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4f720879-1772-e734-e063-6394a90a0cf4	2026-04-14	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d8433c5e-deb3-4f20-aaf6-9fed6bc44974	2026-03-18	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	7976b328-ad8e-4208-9f61-19cd5ab5f36b	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	b773726e-1dc9-415a-81f3-32b43b61b9b1	2026-03-10	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	AvKARE	21b43dab-015c-c82f-ba6e-27da0ec12fc5	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	a328c3e1-9132-491d-ae5b-45fd27ca4993	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d4d0537b-113a-4e49-bb50-bf5ddafe6b7d	2025-12-03	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42897	ORIG	1998-05-08
30716	ORIG	1998-05-08